Senior Director, Regulatory Affairs

Recor Medical•Palo Alto, CA

5d•$260,000 - $280,000

About The Position

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.

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

Responsibilities

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