Regulatory Specialist
5 hours ago
Title: Regulatory Specialist Location: Galway business park, Galway Benefits: Salary, bonus, pension, hybrid working and healthcare Overview: As a Regulatory Specialist you will support the commercialisation of Medical Device products. This includes preparation and submission of regulatory filings for product market entry, as well as regulatory activities required for the maintenance of existing commercial products. The position requires a high level of innovative thought and problem-solving skills. In order to coordinate the variety of regulatory related tasks, the role requires a high degree of flexibility, and structured time and task management Responsibilities: - Contribute to the preparation, review and filing of 510(k) submissions to the FDA for both pre-commercial and commercial products - Prepare and coordinate CE mark submissions/change notifications and Notified Body interactions. - Maintain Technical Documentation according to the requirements of the Medical Device Regulation. - Submit and maintain filings on US and EU regulatory databases (eg FURLS, EUDAMED) - Provide input to the Change Control process for design, manufacturing, and specification changes to assess impact on regulatory compliance and requirements. - Assist in the development and maintenance of device labelling and IFUs to help ensure they comply with regional regulatory requirements - Represent Regulatory Affairs within project teams to provide direction. - Provide regulatory input to customer complaint investigations. - Support post-market surveillance and vigilance activities, including submission of adverse event reports. Requirements: Degree in Engineering or Science discipline Minimum of 2 years experience in the medical device industry Understanding of FDA and/or MDR requirements, with the ability to interpret and implement these requirements Strong technical aptitude with an ability to analyse and challenge data, identify and address gaps, and generate technical reports to support submissions Self-motivated and clear minded approach to regulatory activities Does this sound like your next career move? To apply and for more info forward your application Benefits: Bonus, pension, healthcare, hybrid working
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Part Qualified Practice Accountant
5 hours ago
Galway, Ireland Hays Specialist Recruitment Full timeYour new company You will be joining a well-established and reputable accountancy practice known for its supportive team culture and commitment to professional development. With a strong client base and a collaborative working environment, this firm offers an excellent platform for ambitious professionals to grow their careers. Your new role As a...
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Change Management Specialist
1 week ago
Galway, Ireland Integrity PM Ltd. Full timeCompany Description Integrity PM Ltd is a specialist Project Management consultancy supporting pharmaceutical and life sciences clients across Ireland. We deliver high-impact solutions in GMP environments, with a focus on manufacturing excellence, compliance, and strategic execution. Role Description This is a contract role for a Change Management...
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▷ Urgent: Clinical Research Specialist
2 weeks ago
Galway, Ireland Kelly Full timeReporting to management, this Clinical Research Specialist will contribute to one or more clinical studies within the Clinical R&D team, collaborating closely with colleagues throughout the organization. Key Duties & Responsibilities Provide operational support for company-sponsored clinical studies, helping ensure adherence to project deadlines and...
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Customer Service Specialist
8 hours ago
Galway, Ireland Cpl Full timeCUSTOMER SERVICE SPECIALIST – FRENCH and DUTCH Speaker – Galway - HybridMy client, a Galway City based Global operational hub seeks to hire a Customer Service Specialist initially on a 6 month FTC basis with a view to extension. You will be the first point of contact to support my client’s customers and key distributors across Europe. You will be...
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Principal Specialist Psychologist
3 weeks ago
Galway, Ireland Brothers of Charity Services Ireland Full timeBROTHERS OF CHARITY SERVICES IRELAND - WEST REGION POST OF: TEMPORARY FULL-TIME INTERIM PRINCIPAL SPECIALIST PSYCHOLOGIST CHILDREN'S DISABILITY NETWORK 6 TEAM JOB REF: 87741 The Children Disability Network Services provides support and input to children and young people from age 0 to 18 who have complex needs associated with disabilities. Input and support...
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Galway, Ireland Boston Scientific Gruppe Full timeOccupational Health and Safety Specialist II Location: Galway, G, IE (Onsite) Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most...
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Galway, Ireland CPL Full timeCUSTOMER SERVICE SPECIALIST – FRENCH and DUTCH Speaker – Galway - Hybrid My client, a Galway City based Global operational hub seeks to hire a Customer Service Specialist initially on a 6 month FTC basis with a view to extension. You will be the first point of contact to support my client’s customers and key distributors across Europe. You will be...
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Galway, Ireland Cpl Full timeCustomer Service Specialist –Dutch Speaker – Galway – HybridMy client, a Galway City based Global operational hub seeks to hire a Dutch Customer Service specialist initially on a 12 month contract basis with a view to extension. You will be the first point of contact to support my client’s customers and key distributors across Europe. You will be...
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Occupational Health and Safety Specialist II
5 hours ago
Galway, Ireland Boston Scientific Clonmel Full timeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and...
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▷ (High Salary) EHS Specialist
2 weeks ago
Galway, Ireland Uniting Holding Full timeOverview Catalyx is seeking an Environmental Health & Safety Specialist to join our team and work on our customer site in Galway. Who We Are: Catalyx specialises in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery...
