Job Title: Senior Regulatory Scientist
Overview
The primary role of the Senior Regulatory Scientist is to assist in the running of regulatory affairs by providing input into regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval for commercialising medical devices in selected target markets, and providing regulatory affairs input for functional areas.
Responsibilities
* Assist in running Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
* Implement regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA 21 CFR Part 820 as required and other jurisdictions as needed.
* Maintain an excellent understanding of global medical device regulations.
* Maintain a thorough understanding of products assigned to the team.
* Improve the function of the Regulatory Affairs Department.
* Understand the progress of the RA team on assigned tasks and remove roadblocks.
* Provide support to RA team members to complete assigned tasks.
* Mentor and train new RA team members.
* Highlight updates to regulatory requirements to regulatory management.
* Plan and prepare regulatory submissions for specific target markets for new products, product changes, and re-registrations as needed or collaborate with assigned regulatory specialists.
* Review submissions generated for assigned regulatory area to ensure compliance with regulations in that jurisdiction.
* Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel.
* Advise other Cook functional units (engineering, marketing, operations, quality etc.) on requirements in each target market and update on approval status in target markets.
* Ensure clinical requirements of the product are adequately addressed.
* Ensure outputs from individual functional units meet applicable regulatory requirements.
* Communicate project/submission status directly to RA Management and other stakeholders as required.
* Communicate directly with regional regulatory agencies/notified bodies to ensure product clearances are achieved in a timely manner.
* Serve as liaison on regulatory issues between Cook Manufacturer and Cook International local office and/or Cook distribution partner.
* Coordinate multiple projects at once and provide regular reports to regulatory management and others as required.
* Maintain system for registration information (license numbers, expiration dates etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
* Provide support to currently marketed products as necessary including input on change requests.
* Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
* Provide regulatory support to Cook functional units such as SSC, tenders, customer quality, and distribution.
Qualifications
* Third-level qualification preferably in Science/Quality Engineering or Clinical (such as Pharmacy or Nursing).
* 5 years' experience in a regulated industry in a similar role is desirable.
* Ideal 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 21 CFR Part 820 as required.
* Knowledge of requirements in other jurisdictions where required.
* Knowledge of medical device quality standards/practices or similar regulated industry.
* Good communication and interpersonal 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.