Recor Medical · 1 week ago
Senior Director, Regulatory Affairs
Palo Alto, CA
Full-time
Onsite
Director/Executive
$260K/yr - $280K/yr
12+ years expRecor Medical is pioneering Ultrasound Renal Denervation therapy to treat hypertension. The Senior Director, Regulatory Affairs, will be responsible for developing and implementing global regulatory strategies and preparing regulatory submissions for medical devices.
Health CareMedicalTherapeutics
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
Qualification
Required
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
Company
Recor Medical
ReCor Medical has developed a unique therapeutic non-focused ultrasound system
201-500 employees
H1B Sponsorship
Recor Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (2)
2023 (4)
2022 (3)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$25MKey Investors
Otsuka Holdings
2018-07-10Acquired
2016-06-10Debt Financing· $10M
2015-04-13Series D· $15M
Leadership Team
Lara Barghout
Chief Executive Officer and President
Recent News
2025-10-31
Company data provided by crunchbase