Senior Director, Regulatory Affairs

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

Position Summary

The Senior Director, Regulatory Affairs, will join the ReCor Regulatory Affairs team and report to the SVP, Quality & Regulatory Affairs.  The Senior Director will work closely with the SVP on the development and implementation of global regulatory strategies.  The individual will be responsible for the preparation of US and International regulatory submissions/ product registrations for Class II and Class III medical devices. 

Responsibilities and Duties

• Prepare IDE, PMA, design dossiers and technical files, for US FDA and other international markets.  

• Assist /lead EU MDR implémentation.

• Plan, coordinate, and prepare regulatory submissions

• Develop and manage regulatory timelines to ensure timely submissions. 

• Interacts with internal and external executive level management, requiring negotiation of extremely critical matters Influences policymaking and strategy based on communication strategies and persuasion skills.

• Interface with Regulatory Agencies, such as FDA, Notified Body and competent authorities as required.

• Liaison with existing regulatory consultants on regulatory strategy

• Assist in preparation for PMA panels, as required

• Coordinate with Medical Affairs on the generation of various reports including but not limited to Annual Reports, Clinical Evaluation Reports, Investigator Brochures

• Review and approve internal documents for regulatory compliance

• Review and communicate changes in agency regulations and requirements, and train team accordingly

• Provide regulatory guidance with preparation, review, and approval of advertising and promotional materials

• Interact collaboratively with Clinical, R&D, and Quality, and coordinate regulatory priorities across the company

• Partners with executive leadership team for the function to provide cohesive direction towards company goals

• Participate in new product development teams and develop regulatory strategies.

• Maintain regulatory correspondence and submissions/registrations.

• Knowledgeable in US and international medical device / procedure regulations.

• Continuously evaluate, recommend and implement improvements as needed.

• Willingness to perform other responsibilities as assigned.

• Able to think critically and work collaboratively in a global environment

• Requirements

• Master’s or PH D preferred in life sciences and/or biomedical engineering

• Minimum of 12 years cardiovascular device industry

• Minimum 10+years of management experience

• Minimum of 12 years’ experience in regulatory within the medical device industry

• Prior experience with managing US IDE submissions, PMA experience preferred

• Strong verbal and written communication skills

• Ability to think strategically and critically

• Self-motivated with excellent time management skills

• Create, manage and grow a team

• Perform individual contributor functions, be part of a team, work collaboratively

Salary range: $260,000-   $280,000 (Commensurate with experience, skills, education and training)

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. 

Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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