Regulatory Affairs Specialist 2
The Regulatory Affairs Specialist 2 plays a critical role in developing regulatory strategies and ensuring the compliance of Cook medical devices with global regulations.
Key Responsibilities:
* Maintain a deep understanding of global medical device regulations for specific jurisdictions, including ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21 CFR Part 820.
* Communicate country/region specific regulatory requirements to the RA team and ensure that outputs from individual functional units meet applicable regulatory requirements.
* 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 on regulatory requirements for each target market.
* Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required.
Qualifications:
* Third-level qualification in Science/Engineering; 3-5 years experience in a regulated industry in a similar role desirable.
* 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 interpersonal 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.