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
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 as 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 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.
