Regulatory Affairs Specialist 2

The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates, distribution partners or regulatory authorities.

Reporting to: Team Lead, Regulatory Affairs or

Manager, Regulatory Affairs

Find out more about Cook Medical here

• Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. Knowledge of relevant ISO, Eu, FDA medical device standards regulations is required.
• Ensures a thorough understanding of the products and/or regions they are assigned.
• Communicates country/region specific regulatory requirements of the regions they are assigned to the RA team.
• Develop 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, biocompatibility etc) of the requirements in each target market.
• Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
• Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
• Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
• Communicates directly with notified bodies, distribution partners, Cook affiliates and other regulatory authorities to ensure product approvals are achieved in a timely manner.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
• Provides support to currently marketed products as necessary including input on change requests, regulatory restrictions, 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.
• Performs additional duties as assigned. Can act as a designee for other Regulatory Affairs Specialists if required. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
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• Third level Qualification preferably in Science/Engineering; 3-5 years experience in a regulated industry in a similar role desirable
• 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. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• 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.
• Willingness and availability to travel on company business.