Overview 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 Responsibilities 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.
Qualifications 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.
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