Regulatory Scientist 2

The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs 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.

Reporting to:  Principal Regulatory Scientist

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• Assists in the running of the Cook Ireland 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, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required. 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 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.
• 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 Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• 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.
• 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 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.
• 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 Cook functional units such as the SSC, tenders, customer quality and distribution.
• Is a delegate for the Senior Manager Post Market Surveillance, Regulatory Affairs / Manager, Regulatory Affairs, Principal Regulatory Scientist.
• Is a delegate for the Regulatory Affairs Specialist.
• Is a delegate for the Team Lead, Regulatory Affairs.

Other General Responsibilities

• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
• Perform additional duties as assigned.

• Third level Qualification in any of the following areas: Science, Engineering, or Clinical.
• 2 years’ experience in a regulated industry in a similar role would be advantageous.
• Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation would be advantageous. Particularly in relation to the EU (MDD 93/42/EEC, EU MDR 2017/745). (Clinical & Post Market Surveillance Role)
• Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
• Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form.
• Participate in a team-based environment.
• Proven problem-solving skills.
• Good technical writing skills; advantageous to have medical writing experience.
• Knowledge / use of search databases for published literature (Embase, PubMed etc.)
• Good computer skills including knowledge of Microsoft ^® Office.
• Proven organisational skills.
• High level of self-motivation.
• Willingness and availability to travel on company business as required.