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Job Description
Regulatory Affairs Specialist 2: Develops regulatory strategies, communicates with regulatory authorities, and ensures compliance with global medical device regulations.
The Regulatory Affairs Specialist 2 plays a crucial role in ensuring the compliance of Cook medical devices with global regulations. This involves developing regulatory strategies, communicating with regulatory authorities, and ensuring that all products meet the required standards.
Key Responsibilities:
- Maintain an excellent understanding of global medical device regulations for specific jurisdictions.
- Communicate country/region specific regulatory requirements to the RA team.
- Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel.
- Advise other Cook functional units of the requirements in each target market.
- Plan and prepare regulatory submissions for specific target markets.
- Maintain registration information and obtain re-registration approvals in advance of license expirations.
- Communicate directly with notified bodies, distribution partners, Cook affiliates, and other regulatory authorities.
- Coordinate multiple projects at one time and provide regular reports to regulatory management.
- Provide regulatory support to Cook functional units.
- Perform additional duties as assigned.
Requirements:
- Third-level qualification in Science/Engineering.
- 3-5 years experience in a regulated industry in a similar role.
- 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 21 CFR Part 820.
- 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.