This is a highly specialized role that requires exceptional leadership skills, regulatory expertise, and technical knowledge.
Job Description
The ideal candidate will lead clinical regulatory strategies for high-risk medical devices from early development through market approval.
The primary responsibility of this role is to interpret and apply complex regulatory requirements to clinical trial planning and execution.
A strong team leader with excellent collaboration skills will excel in this role.
Key Responsibilities:
* Develop and lead clinical regulatory strategies for Class III medical devices.
* Interpret and apply complex regulatory requirements to clinical trial planning and execution.
* Collaborate with cross-functional teams including Clinical Affairs, Quality, R&D, and Regulatory Operations.
* Author, review, and submit high-quality clinical regulatory documentation.
* Serve as primary regulatory contact for clinical matters with global health authorities.
The ideal candidate will have a deep understanding of clinical trial design, statistical principles, and regulatory requirements for high-risk medical devices.
A strong leader with excellent communication and collaboration skills will excel in this role.
Requirements:
To be successful in this role, candidates must possess the following qualifications:
* Bachelor's degree in life sciences, biomedical engineering, or a related field required; advanced degree preferred.
* Minimum of 10 years of regulatory affairs experience in the medical device industry, with at least 5 years in a leadership capacity.
* Deep knowledge and hands-on experience with Class III medical devices.
* Proven experience interacting with FDA and other global regulatory bodies on clinical issues.