Director of Regulatory Affairs

Location: Natick, MA

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• $165,000 range + bonus, stock options, Comprehensive Benefit, and Retirement Programs 
• This is direct hire role.
• local candidates only

Our client is a medical device startup developing an innovative, sophisticated, and superior approach to the rapid cessation of bleeding. The Director of Regulatory Affairs is responsible for developing and managing the regulatory strategy for current and future self-assembling material-based products to ensure the timely preparation of organized and scientifically valid regulatory submissions in various geographic jurisdictions.  This individual is also responsible for all regulatory maintenance activities, including periodic reporting requirements for this class III device
 
Responsibilities: 

•  Develop, prepare, execute and manage quality regulatory strategy, filings and communications for medical devices and potentially pharmaceuticals as required for approvals, commercialization, and compliance.
• Provide guidance, develop and oversee strategy to support approved and planned products.
• Identify additional commercial opportunities.
• Develop, manage and interact with domestic and international regulatory authority personnel, consultants and vendors at appropriate stages of development to ensure success of programs.
• Regulatory representative, including mentoring and directing internal and external regulatory resources and representing the company’s regulatory function at regulatory body meetings.
• Represent regulatory strategy to current and potential external partners in business initiatives.
• Develop adequate resources to ensure support of goals and objectives, including implementation and maintenance of systems and procedures to maximize efficiency and compliance.
• Work closely with product development, quality and other teams ensuring regulatory compliance.
• Facilitate environment of cooperation and teamwork to optimize regulatory outcomes.

Who Will Be a Great Fit?  

• 10 + years Regulatory management expertise with significant exposure to medical devices in a regulated industry.
• Prior PMA submission experience
• Proven track record of success leading products through regulatory approval
• Strong budgeting, problem solving, organizational, planning, analytical and skills.
• Highly committed, flexible, self-confident, and comfortable with uncertainty. 
• Fast learner with ability to operate effectively in new environments.
• Ability to gather, integrate, simplify, and explain information from multiple sources.
• Ability to rely on facts and data to assertively influence individuals throughout the company.
• Proactively engage and retain vendors or partners in various countries and cultures.
• Understanding of design controls, quality system, safety regulations, and risk management.