Our client a medical device company in Limerick is looking to hire a Senior Regulatory Affairs Specialist for their site.
The primary role of the Senior Regulatory Affairs Specialist is 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.
Reporting to: Regulatory Affairs Manager
- Assists in the running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
- Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required.
- Works to improve the function of the Regulatory Affairs Department.
- Supports the progress of direct reports on assigned tasks, and provides advice on the removal of roadblocks.
- Mentors and train new regulatory team members.
- Highlights any updates to regulatory requirements to regulatory management.
- Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
- Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
- Develops global regulatory strategies for medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
- Advise other functional units (engineering, marketing, operations, quality etc.) of the requirements in each target market and updates same on approval status in target markets.
- Ensures the biocompatibility requirements of the product are adequately addressed.
- Ensures the clinical requirements of the product are adequately addressed.
- Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
- Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
- Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
- Serves as a liaison on regulatory issues between the Manufacturer and the International local office and/or distribution partner.
- Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
- 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 an excellent understanding of the global medical device regulations.
- Maintains a thorough understanding of the products assigned to the team.
- 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 the Code of Conduct is considered in all business matters carried out on the company’s behalf.
- Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
- Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required.
- Knowledge of requirements in other jurisdictions where required.
- Knowledge of medical device quality standards/practises or similar regulated industry.
- 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.
For further information on this Senior Regulatory Affairs Specialist role in Limerick please contact Clara Burke on 086 8168273/ email@example.com
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