Our client is a clinical stage disruptive healthcare company working to revolutionize the detection of pulmonary infections. The product is a combination drug /device that can detect and monitor pulmonary infections within minutes.
The Head of Regulatory Affairs will provide strategic leadership for regulatory strategy, agency interactions, and submissions for this novel technology. You will be responsible for developing, implementing and advising on global regulatory strategies to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. You will interface with outside regulatory agencies based on reporting requirements and business circumstances, and internal business partners in regards to development and execution of regulatory strategies. This position will report directly to the Chief Executive Officer.
You will be setting the strategy and managing every aspect of regulatory affairs
You will work with an experienced team of entrepreneurs who are passionate about the work they do with a track record of previous successes
You will be a key player on a team responsible for the company’s growth
You will participate in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
Provide leadership in the design and execution of strategies for complex regulatory submissions
Manage and prepare regulatory documents and submissions
Direct the strategy of interactions with the respective regulatory health authorities
Interpret regulatory requirements for all company filings; process and submit filings.
Represent company before regulatory authorities.
Interact and collaborate with regulatory agency in regard to submission and subsequent approvals and any proposed changes to regulations.
Compile and author documents for submission to regulatory agencies, including premarket notification submissions and pre-market approval applications.
Ensures corporate compliance for manufacturing licenses, government reporting requirements, etc.
Provides technical regulatory input to business development and collaboration opportunities.
Interprets changes in regulatory landscape and communicates impact to senior leadership.
As the company grows, build a strong regulatory affairs team to meet regulatory needs.
Develops and mentors regulatory personnel and future regulatory staff.
Represent regulatory with internal and external partners.
Work with reimbursement specialists to determine U.S. and international regulatory and reimbursement strategies.
BA/BS Degree is required, advanced degree and/or RAC a plus
12 years of progressive advancement within regulatory affairs supporting medical devices and/or combinations products.
Demonstrated track record of successful regulatory submissions and maintenance of IDEs/PMAs
Experience in taking products through a complete regulatory cycle from development through launch both in and outside the U.S.
Creative thinker with demonstrated ability to gain regulatory approval for a novel device or application
Ability to read, understand and interpret medical device, FDA and EU regulations and requirements
Ability to inspire, motivate and develop regulatory team and members.
Demonstrated advocacy and negotiation skills
Good commercial orientation, coupled with the ability to make sound decisions under pressure with reasonable foresight as to outcomes.
Ability to be in the office 2-3 days per week
Additional Salary Information: Compensation includes base salary, annual bonus and long term incentive commensurate with experience.