OverviewThe Regulatory Affairs Specialist 2 helps develop regulatory strategies and 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
ResponsibilitiesMaintain 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.Ensure a thorough understanding of the products and/or regions they are assigned.Communicate 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 personnel (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.Plan and prepare regulatory submissions for specific target markets for new products, product changes, and re-registrations as required.Maintain registration information (license numbers, expiration dates, etc.)
and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.Communicate the clinical requirements for regulatory registrations for the product and work as part of a cross-functional team to ensure that they are adequately addressed.Communicate directly with notified bodies, distribution partners, Cook affiliates, and other regulatory authorities to ensure product approvals are achieved in a timely manner.Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.Serve as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.Provide support to currently marketed products as necessary, including input on change requests and regulatory restrictions.Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.Provide regulatory support to Cook functional units such as the SSC, tenders, customer quality, and distribution.Perform 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.QualificationsThird 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 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 Office.Proven organizational skills.High self-motivation.Willingness and availability to travel on company business.
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