At ZOLL®, we know that millions of people worldwide are relying on our medical devices to help provi
Location: Chelmsford, Massachusetts
Type: Full Time
Internal Number: R8372
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.
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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.
ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
About At ZOLL®, we know that millions of people worldwide are relying on our medical devices to help provi
ZOLL Medical Corporation is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!