Director, Regulatory Affairs
ZOLL Medical Corporation
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!
The Director of Regulatory Affairs is responsible for developing, implementing, and leading both regional and international regulatory strategy for ZOLL products, while representing the firm in various cross-functional project teams. Reports to Vice President, Quality Assurance and Regulatory Affairs.
- Global regulatory leadership for new and marketed medical device products.
- Liaison with the FDA and other regulatory agencies, as necessary, including arranging and attending face-to face meetings.
- Ability to formulate, create, and implement regulatory strategies and related activities needed to secure approvals.
- Preparation of PMA annual reports to FDA.
- Contributor and reviewer of product labeling.
- Preparation of amendments/supplements for IDEs, new device applications, 510(k)s, PMAs, technical files/documentation (MDD & MDR), and design dossiers (MDD).
- Lead international product registrations.
- Support cross-functional project teams and provide regulatory guidance.
- Maintain current knowledge of regulations and guidances; review impact on ZOLL products, disseminate information, and potential strategies with teams.
- Identify and interface with other departments as necessary to implement corrective actions.
- Collect, analyze, and disseminate department key-performance indicators and metrics.
- Coordinate department responsibilities with other departments to ensure smooth workflow and timely completion of tasks.
- Review and approve engineering change orders.
- Must have leadership responsibility experience for regulatory affairs on project teams.
- Must have liaison and significant submission experience with the FDA (510k, PMA) EU notified bodies (EU-MDR Class II and III).
- Must have experience with other international submissions (e.g., Japan, Australia, China, etc.).
- Strong global regulatory knowledge.
- Experience with clinical evaluation reporting requirements.
- Experience with biocompatibility and other product standards.
- Strong business acumen and critical thinking skills.
- Effective delegator and a forward thinking visionary responsible for the management of global people development roadmaps including talent leadership and competency development.
- Strong understanding of medical device product development.
- Ability to put actions/projects in place to meet customers' expectations.
- Experience establishing departmental budgets and cost projections.
- Must be able to multitask effectively.
- Must have excellent written and communication skills with the ability to interface well with management, internal multi-disciplinary staff, FDA, notified bodies, and other international regulatory authorities.
- Outstanding cross-functional team collaboration skills.
- Requires travel.
Required/Preferred Education and Experience:
- Bachelor's degree in a relevant science is required. Engineering and advanced degrees preferred.
- A minimum of 10 years experience in regulatory affairs (including FDA liaison, global regulatory submissions preparation and successful approvals, regulatory support of product development, and project management).
- A minimum of 5 years of regulatory affairs management experience, including management of large teams
- RAC (Regulatory Affairs Certification) a plus.