Senior Regulatory Affairs Officer
The Senior Regulatory Affairs Officer helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets. The Senior Regulatory Affairs Officer serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities.
- 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.
- Coordinates multiple projects at one time and provides regular reports to regulatory management
- Serves as a liaison on regulatory issues between the manufacturer and the international affiliate in the designated territory.
- Provides support to currently marketed products as necessary including input on change requests, etc.
- Performs additional duties as assigned.
Education and Experience:
- Third Level Qualification preferably in Science/Engineering; 3 years experience in a regulated industry in a similar role desirable
- Has knowledge of regulatory requirements in accordance with ISO13485, MDD93/42/EEC and FDA QSR 21CFR Part 820 as required.
- Knowledge of medical device quality standards and guidance documents
- Good communication and inter-personal skills
- Ability to present at local departmental meetings
- Proven problem-solving skills
- Good computer skills including knowledge of Microsoft Office.
For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email firstname.lastname@example.org