Senior Regulatory Affairs Officer
Our client, a leading Medical Device company in Sligo, is looking to hire a Senior Regulatory Affairs Officer.
- Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned.
- Ensures a thorough understanding of the products they are assigned.
- Communicates country/region specific regulatory requirements.
- Develop global regulatory strategies for medical devices in collaboration with R& D and clinical functions.
- Advise other functional units (R&D, engineering, marketing, quality etc) of the requirements in each target market.
- Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
- Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
- Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
- Communication of the clinical requirements for regulatory registrations for products and work as part of a cross functional team to ensure that they are adequately addressed.
- Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
- Serves as a liaison on regulatory issues between the manufacturer and the international affiliate in the designated territory.
- Leads regulatory team on site and remotely.
- Third Level Qualification preferably in Science/Engineering; 5 years’ experience in a regulated industry in a similar role desirable
- Has knowledge of regulatory requirements in accordance with ISO13485, MDD93/42/EEC MDR, and FDA QSR 21CFR Part 820 as required.
- Knowledge of medical device quality standards and guidance documents.
For a confidential discussion and more information on the role, please contact Mark Whelan.