The Regulatory Affairs Specialist is responsible for preparing global regulatory strategies and associated regulatory submissions. The incumbent possesses knowledge of regulatory requirements gained through experience and is able to perform the essential duties and responsibilities with some direct supervision. Travel, both domestic and international, may be required up to 10% of time.
Essential Duties and Responsibilities
- Develop global regulatory strategies in support of new and modified medical devices
- Prepare global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices
- Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets
- Communicate with US FDA and other regulatory agencies, as needed, to support the development of regulatory strategies and regulatory submissions in-progress or under review
- Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements
- Assess engineering change requests (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance
- Review product labeling and to ensure compliance with US and international requirements
Education: Bachelor's degree preferably in a clinical, medical, or scientific/technical discipline
- It is preferred for candidate to have a minimum of 3-5 years of regulatory submissions experience in the medical device industry
- Working knowledge of FDA and applicable international regulations required
- Knowledge of computer-assisted surgical devices and medical device software, along with regulatory requirements, standards and guidance for both, desired
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Veterans are strongly encouraged to apply.