Job Description:
The Senior Regulatory Scientist plays a critical role in the regulatory affairs team, providing input into regulatory strategies and ensuring compliance with global medical device regulations.
Key Responsibilities:
* Assist in the implementation of regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA 21CFR Part 820
* Maintain an excellent understanding of global medical device regulations and product assignments
* Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel
* Advise functional units on regulatory requirements and updates
* Ensure clinical requirements are adequately addressed and outputs meet applicable regulatory requirements
* Communicate project status directly to RA Management and stakeholders
Qualifications:
* Third-level qualification in Science, Engineering, or Clinical
* 2 years' experience in a regulated industry in a similar role
* Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation
* Good communication and interpersonal skills
* Proven problem-solving skills
* Good technical writing skills and computer skills