Senior Regulatory Affairs Specialist, Medtech
Our client seeks a Senior Regulatory Affairs Specialist for managing and coordinating Regulatory activities necessary to ensure compliance with EU medical device legislation MDR/IVDR, ISO13485, ISO9001, ISO14971.
Flexibility for this hire to work remotely with occasional travel to Dublin site, when required. Again, this company are flexible to hire full-time or part-time.
The successful candidate will lead development, implementation and execution of regulatory, clinical and compliance support strategies for medical devices, in-vitro diagnostics and drug-device borderline / combination products.
The ideal candidate will be an experienced Regulatory Affairs professional with 5+ years’ experience in Medtech industry to (MDR 2017/745 and IVDR 2017/746), with proven ability to work under own initiative and strong team player.
Key responsibilities for this role:
Evaluating classification and due diligence review of technical, preclinical and clinical data for regulatory submissions.
Development of EU MDR/IVDR technical documentation covering a wide range of medical technologies.
Plan, manage, collate, submit and follow up with Competent Authority and Notified Body submissions.
Maintain compliance of CE technical documentation aligned with device and process changes as per relevant regulatory requirements.
Designing, planning, implementing and delivering training on quality and risk management systems in accordance with EU requirements.
Networking and ongoing liaison with the CAs and Notified Bodies NBs in Europe. Experience in other territories an advantage.
Requirements for Senior Regulatory Affairs Specialist, Medtech
Bachelor’s Degree in Science, Pharmacy, Engineering or another relevant science discipline.
5+ years’ experience in a Regulatory Affairs role within an ISO13485 and ISO14971 EU regulated medical device environment.
Proven experience with technical documentation elements to CE mark a medical device, IVD or combination product in Europe.
Substantial experience in liaising with various relevant competent authorities / notified bodies in Europe.
Some experience with drug-device combinations a distinct advantage.
Must have the ability to communicate effectively with management and fellow peers.
Hands-on approach to work and good problem-solving abilities.
Strong attention to detail and high level of accuracy in all aspects of the position.
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.