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    Regulatory Affairs Manager  

    - Ballina

    We Make Life More Rewarding and Dignified Location: Ballina Department: Regulatory Summary The Regulatory Affairs Manager is an experienced individual contributor responsible for developing, executing, and maintaining global regulatory strategies to support the timely commercialization and continued compliance of medical device products. The role partners closely with cross‑functional stakeholders to ensure products meet applicable regulatory, quality, and safety requirements across global markets. This role serves as a subject matter expert in global regulatory requirements, including U.S., EU, and international regulations, such as EU MDR, FDA requirements. The Regulatory Affairs Manager provides regulatory guidance across the product lifecycle, and may act as or support the Person Responsible for Regulatory Compliance (PRRC) or the EU Authorized Representative (AR), where assigned/based on location. The position promotes regulatory excellence through education, collaboration, and continuous improvement. Responsibilities Develop and implement global regulatory strategies and associated activities to support new product development, product lifecycle management, and global market access. Lead, prepare, review, and support regulatory submissions, registrations, renewals, and regulatory change notifications globally. Assess the regulatory impact of product, labeling, manufacturing, system, and data changes and secure timely regulatory approvals. Serve as a regulatory subject matter expert, providing interpretation of applicable regulations, standards, and guidance documents, possessing a deep understanding of medical device regulations, including but not limited: US: 21 CFR Part 820 Canada: Medical Device Regulations SOR/98-282 EU: Medical Device Directive 93/42/EEC and Medical Device Regulations (2017/745) Brazil: Classification and Registration Requirements of Medical Product RDC 185/2001 and GMP Requirements for Medical Devices and IVDs RDC 665/2022 Japan: Pharmaceutical and Medical Device Act (2014) Australia: Therapeutic Goods (Medical Devices) Regulations 2002 Support or perform PRRC or EU AR responsibilities, ensuring technical documentation, declarations of conformity, and compliance records are maintained. Collaborate cross‑functionally with R&D, Quality, Clinical, Labeling, IT, Operations, Marketing, and external partners (e.g. distribution partners) Lead or support regulatory compliance projects and continuous improvement initiatives. Prepare and maintain regulatory documentation, reports, and compliance records. Review and approve labels, instructions for use, and advertisement and promotional materials. Support post‑market activities (i.e. non‑conformances, risk assessments, complaints) and internal and external audits (i.e. EU MDR, MDSAP, ISO 13485, ISO 14971) Acts as a liaison with the government authorities. Develop and deliver regulatory training and education to internal stakeholders. Participate in industry working groups and monitor industry best practices as appropriate. Essential Functions Of The Role Communicate effectively via email, phone, and virtual platforms. Collaborate across departments to support organizational goals. Participate in cross‑functional meetings and initiatives. Prepare reports and dashboards for internal stakeholders. Ensure data accuracy and confidentiality in compliance with company and legal standards. Manage multiple priorities and deadlines in a fast‑paced environment. Lead or support special projects aligned with departmental objectives. Demonstrate initiative in identifying process improvements or automation opportunities. Serve as a point of contact for internal and external stakeholders. Resolve inquiries and issues with professionalism and discretion. Adhere to company policies, including those related to ADA, data privacy, and ethics. Maintain secure handling of sensitive information. Travel frequently, including overnight and occasional weekend travel. Occasional lifting of materials up to 15 pounds may be required. Education & Work Requirements Bachelor’s Degree with 8-12 years of related experience Education & Work Preferences Master’s degree preferred. Equivalent combination of education and experience may be considered. Regulatory credential or equivalent preferred (such as RAC from RAPS) Competencies Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles. Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do. Be People‑Focused - Builds trust and collaborates with an inclusive and empathetic approach. Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes. Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles. EOE Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr

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    Administrator – Early Learning and Care Programme Position: Administrator – Early Learning and Care Programme within the Ballybunion Community Centre, part of the Community Employment Programme. Responsibilities Interact with the public and respond to inquiries. Answer telephone calls and provide assistance. Perform office tasks such as photocopying, filing, and other administrative duties. Support and collaborate with the administration team. Qualifications Strong written and spoken English skills. Ability to obtain character references and comply with Garda vetting procedures. No prior experience required; accredited training will be provided to support your career. #J-18808-Ljbffr

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    N W SOCIETY PREVENTION OF CRUE, Market Road, Ballina, Co. Mayo, F26 HK75 Eligibility to participate on CE is generally linked to those who are 21 years or over and in receipt of a qualifying social welfare payment for 1 year or more or 18 years and over for certain disadvantaged groups. Your eligibility will have to be verified by the Department. To register your interest you can contact an Employment Personal Advisor (EPA) in your local Intreo Centre. Job Description Duties This is a developmental opportunity, no experience necessary. Accredited training will be provided to support your career. NWSPCA Ballina is currently seeking a Retail Assistant for a Community Employment (CE) placement in our charity shop. This role offers valuable work experience in a friendly, community-focused environment while supporting animal welfare. Assisting customers and providing good customer service Operating the till and handling cash Sorting, pricing, and displaying donated stock General shop duties and maintaining a clean, welcoming environment Ideal candidates will: Be eligible for the Community Employment scheme Have a positive attitude and willingness to learn Enjoy working with the public and as part of a team #J-18808-Ljbffr

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    Summary From our Head Office to the shop floor and everywhere in between our primary goal is to create and deliver a fantastic customer journey for everyone who shops at Lidl. Customer obsessed, high energy and love learning every day? If that sounds like you, earn €460+ per week as a Customer Assistant on our standard 30 hour contract. You’ll work across different shift times, on varied tasks and with different colleagues. What does a normal day* as a Customer Assistant look like? (*there’s no such thing as ‘normal’ in retail but we’ve tried our best!) As a Customer Assistant you are required to sell alcohol, therefore you must be 18 or over to work in our store. Shift Patterns Morning shift: Starting at 5am or 6am with your team, you’ll be getting our award-winning products fully stocked on the shop floor and our delicious bakery products ready for our customers to enjoy by opening time so they can Go Full Lidl! Middle shift: Starting mid-morning or early afternoon, you’ll make sure our stores are spotlessly clean, well presented and our products remain fresh, all while helping customers with queries on the shop floor and working on tills to minimise till queues. Late shift: From your start time in the afternoon, you’ll make sure our customers experience is top class by serving them with a smile while on the tills, restocking missing items and getting the store ready for the next day. What You’ll Do Interacting with the customer in a pleasant, friendly and helpful manner Ensuring stock loss controls are followed in all areas of the store Maintaining store and external cleanliness and hygiene standards Following freshness and rotation principles Ensuring all waste is managed correctly Assisting in the stock count process What You’ll Need A can‑do attitude and excellent customer service skills The willingness to go the extra mile for our customers To be responsible and reliable To enjoy working in a fast‑paced, varied environment A good team player Preferably, previous experience in a customer facing role but this is not essential provided you have the right attitude What You’ll Receive We offer a competitive and transparent salary system, that ensures pay equality across all positions at Lidl. €15.40 rising to €17.90 per hour after 3 years (supplementary pay outlined below) Unsocial hours worked (12am to 7am) 20 days holidays per annum pro rata Company pension Genuine opportunities for career development Individuals recognised as high performing will be invited to join our Leadership Academy as part of your on‑going development Circle K and Private Health Insurance discounts available for all employees Bike to Work Scheme Mobile and broadband discounts with Three network Maternity & Paternity Leave top up, Marriage Leave, Employee Assistance Programme Year 1 Basic Rate €15.40 €19.25 (Unsocial Hours) €23.10 (Overtime/Sundays) €30.80 (Bank Holiday) Year 2 Basic Rate €16.20 €20.25 (Unsocial Hours) €24.30 (Overtime/Sundays) €32.40 (Bank Holiday) Year 3 Basic Rate €16.90 €21.13 (Unsocial Hours) €25.35 (Overtime/Sundays) €33.80 (Bank Holiday) Year 4 Basic Rate €17.90 €22.38 (Unsocial Hours) €26.85 (Overtime/Sundays) €35.80 (Bank Holiday) Lidl is an equal opportunities employer. If you have any particular requirements, we will ensure any reasonable accommodations are implemented as part of the recruitment and selection process. We value diversity and inclusion in our workplace and want to ensure that all applicants have the same opportunity regardless of gender, civil status, family status, sexual orientation, age, disability, race, religious belief, political opinion or membership of the traveller community. #J-18808-Ljbffr

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    Domestic Linguistic Interpreter (student) Join a dynamic team at Fort Henry National Historic Site of Canada, part of a UNESCO World Heritage Site, that provides visitors with an understanding of historic military life through guided tours, interpretation, heart‑pounding musical performances and precision military demonstrations. Position Domestic Linguistic Interpreter (student) Hours of Work Variable up to a maximum of 36.25 hours per week. Must be able to work weekends, holidays and evenings as required. Division/Location Fort Henry Guard, Fort Henry National Historic Site of Canada – Kingston, Ontario Salary $18.45 per hour Period of Employment May 4 to September 7, 2026 Responsibilities Be a representative of one of Kingston’s premium and internationally recognized tourism sites. Interpret the role of a garrison domestic member of 1867‑era British North America in English and French. In period costume, interpret the history of Fort Henry National Historic Site of Canada – part of a UNESCO World Heritage Site – by leading guided tours, participating in historical dramatizations, events, parades and performances, and providing spoken commentary. Offer interpretation in any other languages you are fluent in (e.g., Mandarin, German, Punjabi). Perform before Fort Henry visitors and attend internal and external special events. Deliver excellent customer service to ensure each guest’s experience is interesting and enjoyable. Work safely and report unsafe activities immediately to your supervisor. Embody the St. Lawrence Parks Commission’s equity, diversity and inclusion principles when interacting with staff and guests. Possible Roles A soldier’s wife Garrison School Mistress An Officer’s Wife Garrison Schoolmaster Barrack Room Orderly Garrison Pioneer Qualifications and Skills Acting & Performance Skills Ability to work in a fast‑paced, high‑stress environment and meet high performance expectations. Capable of learning historical information, especially Canadian and/or British military and social history around 1867, within a limited timeframe and presenting it to the public in both individual and group settings. Ability to portray a historical character and perform the role in public. Strong communication and interpersonal skills for program delivery, customer service, and effective information sharing with the public and staff. Language Skills Fluency in English and French. Physical Skills High degree of physical fitness to meet the physical demands of the position. Safety Skills Ability to learn all safety protocols and procedures to ensure personal, guest, and fellow staff safety at all times. A vulnerable sector check is required for this position. Equal Employment Opportunity Statement St. Lawrence Parks Commission is committed to employment equity. We welcome applications from people with disabilities, Indigenous, Black and racialized individuals, and people from diverse ethnic and cultural origins, sexual orientations, gender identities and expressions. The Commission is also committed to an inclusive, barrier‑free selection process. Appropriate accommodations will be made throughout the recruitment and selection process for applicants with disabilities. To obtain a copy of this posting in an alternative format or to request an accommodation, please contact Human Resources at 1‑800‑437‑2233, ext. 1401. Accommodation requests will be addressed confidentially. #J-18808-Ljbffr

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    IRD North Mayo West Sligo Ltd in Ballina is seeking a Retail Assistant for a Community Employment placement in their charity shop. This role provides the opportunity to gain valuable work experience in a friendly community-focused environment while supporting animal welfare. Ideal candidates should have a positive attitude and a willingness to learn, alongside the ability to work well with the public and as part of a team. Training will be provided, and no experience is necessary. #J-18808-Ljbffr

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    Do You Love Bringing Joy to Others? Passionate About Making a Difference in Older People’s Lives? Join Our Amazing Activities Team Today! Activities Co-ordinator We are looking for compassionate, energetic, and creative individuals to join our supportive and dynamic team as an Activities Co-ordinator . If you love engaging with people and making each day special, we want to hear from you! This role is part-time, 18 hours per week. Why Choose Us? Flexible Scheduling - Work shifts that accommodate both your availability and our needs! Competitive Pay & Benefits - Enjoy great rates, fortnightly pay, and a range of employee perks. Career Growth & Training - Induction program and ongoing development. Education Assistance Program - We invest in YOU! All Meals Provided on Duty - Enjoy delicious meals while you work. Free Uniform & Name Badge - Look and feel professional. Supportive, Friendly Work Environment - Be part of a caring team. Well-Being Initiatives - We care about our staff’s health & happiness. Employee Referral Bonus - Get rewarded for bringing great people onboard! Free On-Site Parking - Stress-free commuting. What You’ll Do Organise and facilitate engaging activities for residents. Create person-centred programmes that bring joy and purpose. Set up and arrange spaces for activities in a safe manner. Build meaningful relationships with residents and the local community. Maintain records of engagement and activity participation. Promote and practise the ethos of person-centred care. What We’re Looking For FETAC/QQI Level 5 in Healthcare or a related field. Additional training in Care of the Older Person, Dementia Care, or Palliative Care is a plus (or willingness to complete). Valid certifications: CPR, Infection Control, Manual Handling, and Safeguarding (training available if needed). Experience working in elderly care within a residential setting. Special skills in gardening, knitting, cooking, music, arts and crafts are an advantage. Full Irish Driver’s Licence required. If this sounds like you, do not wait— apply now! All applications are handled with the strictest confidence. Sonas is an Equal Opportunities Employer. Visit www.sonas.ie to learn more! #J-18808-Ljbffr

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    Retail Merchandiser – Ballina NSW (Car and License Required) Employment Type – Casual Location: Ballina, Lennox Head, Alstonville or surrounding areas. Benefits Competitive casual hourly rate $32.79 per hour + $0.98 per km + superannuation Flexible work, scheduled 5-7 days in advance Autonomy and work-life balance Paid training, ongoing support and career development pathways Immediate start Work with Australia’s leading brands and retailers Referral programs, ongoing training, recognition and career opportunities Responsibilities Creating and setting up eye-catching product displays for leading brands Talking to store teams about promotions for big brand names Using the StoreTrack app to upload task reports, photos and send quick updates Day-to-day tasks include merchandising in retail environments Requirements A valid driver’s license and reliable car (no learner’s permits accepted) Availability at least 3-4 days a week during business hours (including Wednesday and Thursday) Morning start required Great communication, organisation and self-motivation No merchandising experience required – training will be provided #J-18808-Ljbffr

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    St. Brigids Community Centre in Ballina is seeking an Administrator for the Early Learning and Care Programme. This position involves interacting with the public, answering inquiries, and performing various office tasks. Strong written and spoken English skills are essential, and candidates must comply with Garda vetting procedures. No prior experience is required as accredited training will be provided to support professional development. #J-18808-Ljbffr

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    Sonas Nursing Homes in Ballina is seeking a compassionate Activities Co-ordinator to join our dynamic team. This part-time position (18 hours per week) involves facilitating engaging activities that enhance residents' lives. Suitable candidates will hold FETAC/QQI Level 5 in Healthcare, have experience in elderly care, and possess a Full Irish Driver's Licence. We offer flexible scheduling, competitive pay, and numerous employee perks including meal provision and career growth opportunities. #J-18808-Ljbffr



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