Senior Regulatory Affairs Specialist

Overview

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.

 

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Responsibilities

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

 

Qualifications

• 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.

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