Regulatory Affairs Specialist 2
The Regulatory Affairs Specialist 2 plays a vital role in developing regulatory strategies and obtaining/maintaining regulatory approval to commercialize medical devices in targeted markets.
Key Responsibilities:
* Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned, including ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21CFR Part 820.
* Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel, particularly for high-risk devices.
* Advise Cook functional units (engineering, marketing, operations, quality, biocompatibility, etc.) on regional requirements and ensure their outputs meet applicable regulatory requirements.
* Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required.
* Communicate directly with notified bodies, distribution partners, Cook affiliates, and regulatory authorities to ensure timely product approvals.
Requirements:
* Third-level qualification in Science/Engineering; 3-5 years of experience in a regulated industry in a similar role is desirable.
* Knowledge of relevant ISO, EU, and FDA medical device standards regulations is required.
* Good communication and interpersonal skills, proven problem-solving skills, and high self-motivation are essential.
About the Role:
This role serves as a liaison between the Cook manufacturer and local affiliates, distribution partners, or regulatory authorities, ensuring effective communication and collaboration.
The ideal candidate will have excellent organizational skills, good computer knowledge, and the ability to travel on company business.
What We Offer:
Cook Ireland Ltd. offers a dynamic work environment, opportunities for growth and development, and a competitive compensation package.