Senior Regulatory Affairs Specialist
Ref No: SF17007
Limerick, Co. Limerick, Ireland
Senior Regulatory Affairs Specialist- Limerick
A large Multinational Medical Device Client is recruiting a Senior Regulatory Affairs Specialist to lead a team & manage projects, providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.
This role reports to the Regulatory Affairs Manager
- Assists in the running of the regulatory affairs programs in line with internal procedures and in accordance with regulatory requirements. ISO13485, MDD 93/42/EEC, EU-MDR 2017/745 and FDA 21CFR Part 820, and other jurisdictions as required.
- Maintains an excellent understanding of the global medical device regulations related to Class 2a, 2b, 2b implantable and Class 3 Drug Device products and how these regulations apply to products.
- Maintains an excellent understanding of the applicable standards, harmonised, ISO, ASTM etc related to the products.
- Highlights any updates to regulatory requirements with regulatory management and works with the applicable stakeholders to develop a strategy to implement any subsequent changes.
- Develops global regulatory strategies for medical devices in collaboration with other regulatory affairs or clinical personal, especially on high-risk devices.
- Advises other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and update same on approval status in target markets.
- Works with other functional units (engineering, marketing, operations, quality etc.) to ensure that the relevant documentation (Design Reviews, Process qualifications, Protocols and reports etc.) are adequate to meet the relevant regulatory need.
- Provide subject matter expertise and guidance related to applicable regulatory requirements, including but not limited to Clinical evaluation reports (CER MEDEV 2.7.1 Rev 4), Post Market surveillance (Post Market Clinical
- Follow Up and Periodic Safety Update Reports), Design Dossiers, Risk Management Files, Biocompatibility, Sterilisation and Product Labelling.
- Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed.
- Liaise and negotiate with the Notified Bodies, Competent Authorities, FDA etc. to ensure that planned actions will satisfy the regulators expectations.
- Coordinates multiple projects and communicates status of projects/submissions directly to RA Management and other stakeholders as required.
- Act as a liaison on regulatory issues between the Manufacturer and the International local office and/or distribution partner.
- Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
- Provides support to currently marketed products as necessary including input on change requests, etc.
- Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
- Provides regulatory support to functional units such as the SSC, tenders, customer quality and distribution.
- Ensure that a Code of Conduct is considered in all business matters carried.
Experience & Qualifications:
- Third level Qualification in Science/Quality preferred.
- 5 years’ + experience in a regulated industry in a similar role is desirable.
- Knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU-MDR 2017/745 and FDA 21CFR Part 820
- Knowledge of requirements in other jurisdictions.
- Knowledge of medical device quality standards/practises or similar regulated industry.
- Good communication and inter-personal skills.
- Proven problem-solving, prioritisation & organisation skills.
- Good computer skills including knowledge of Microsoft packages
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