Regulatory Affairs Specialist 2
This role helps develop regulatory strategies, ensuring medical devices comply with regulations for commercialization in target markets.
Key Responsibilities:
* Maintain knowledge of global medical device regulations, including ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21 CFR Part 820.
* Communicate country-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 functional units on market requirements and ensure outputs meet regulatory standards.
* Plan and prepare regulatory submissions for new products, product changes, and re-registrations.
* Maintain registration information and obtain re-registration approvals to ensure product availability.
* Coordinate multiple projects and provide regular reports to regulatory management.
Requirements:
* Third-level qualification in Science/Engineering; 3-5 years experience in a regulated industry.
* Knowledge of medical device quality standards/practices or similar regulated industry.
* Good communication and interpersonal skills.
* Proven problem-solving skills.
* Good computer skills, including Microsoft Office.
* Proven organizational skills.
* High self-motivation.
* Willingness to travel on company business.
Qualifications:
A degree in Science/Engineering is preferred, along with experience in a regulated industry. Knowledge of MDSAP countries and medical device quality standards/practices is also beneficial.
About This Role:
This position requires strong communication, problem-solving, and organizational skills. The ideal candidate will have a thorough understanding of medical device regulations and be able to develop effective regulatory strategies.