Senior Regulatory Affairs Specialist

The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the Regulatory Affairs department by 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.

Find out more about Cook Medical here

• Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
• Knowledge of relevant ISO EU FDA medical device standards regulations is required.
• Maintains an excellent understanding of the global medical device regulations.
• Maintains a thorough understanding of the regions and/or products assigned to the team.
• Works to improve the function of the Regulatory Affairs Department.
• Understands the progress of the RA team on assigned tasks and removes roadblocks.
• Provides support to the RA team members to complete assigned tasks.
• Mentors and trains new RA team members.
• Communicates country/region specific regulatory requirements of the regions they are assigned to the RA team
• Plans and prepares regulatory submissions for specific target markets for new products product changes and re-registrations as needed and collaborates with their assigned regulatory specialists on same in any jurisdiction.
• Ensures the clinical requirements of the product are adequately addressed.
• Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that jurisdiction.
• Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable).
• Advise other Cook functional units (engineering marketing operations quality etc) of the requirements in each target market and updates same on approval status in target markets.
• 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/distribution partners/Cook affiliates to ensure product clearances are achieved in a timely manner.
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Provides support to currently marketed products as necessary including input on change requests regulatory restrictions
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Provides regulatory support to Cook functional units such as the SSC tenders customer quality and distribution.
• Is a delegate for other Regulatory Affairs Specialists Senior Regulatory Scientist and the Team Lead Regulatory Affairs.
• Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cooks behalf.
• Perform additional duties as assigned.

• Third level Qualification preferably in Science/Quality Engineering
• 5 years experience in a regulated industry in a similar role is desirable.
• Ideally have knowledge of requirements in MDSAP countries.
• 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
• Proven organisational skills.
• High self-motivation.
• Willingness and availability to travel on company business.

#LI-AK1