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Job Description
Regulatory Affairs Specialist 2 ensures EU MDR compliance at the office of the EU Authorised representative, verifying compliance on behalf of non-EU manufacturers.
The role involves maintaining an excellent understanding of EU medical device regulations, ensuring thorough product knowledge, and working with global and local teams to implement EU MDR requirements.
Key responsibilities include:
- Maintaining a thorough understanding of EU medical device regulations, including EMEA, UK, Switzerland, and EN ISO13485
- Ensuring processes and procedures are in place and maintained as part of the QMS to carry out the role of EU AR as per Article 11 of EU MDR
- Liaising with and responding to requests for information and/or documentation/samples from Competent Authorities
- Informing relevant CA's of any reportable incidents and field safety corrective actions
- Completing EU AR obligations as outlined under Article 11 and 12 of EU MDR
- Monitoring post-market surveillance and legislative and regulatory activities
- Coordinating multiple projects and providing regular reports to regulatory management
- Serving as a liaison on regulatory issues between the Cook Manufacturer and the Office of EU Authorised Rep
- Providing regulatory support to Cook functional units
- Providing support for regulatory audits
- Performing additional duties as assigned
Qualifications:
- Third-level qualification in Science/Engineering or Law
- 2-5 years' experience in a regulated industry in a similar role
- Knowledge of EU-MDR, Regulation (EU) 2017/745, Medical device Directive (93/42/EEC)
- Knowledge of relevant ISO, EU, FDA medical device standards regulations
- Good communication and inter-personal skills
- Proven problem-solving skills
- Good computer skills, including knowledge of Microsoft Office
- Proven organisational skills
- High self-motivation
- Approved External Auditor
- Willingness and availability to travel on company business