The Regulatory Affairs Specialist 2 helps develop regulatory strategies and performs activities associated with obtaining and maintaining regulatory approval to commercialize 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.
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.
* 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, 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.
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.
* 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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