Well-funded start-up launching clinical trials of cardiovascular devices that prevent stroke in patients with Atrial Fibrillation, which is a problem affecting 30% of the 5 million AFib patients in the US alone. The company’s innovative technology simplifies a widely accepted procedure, improves the patient experience, demonstrates equivalent outcomes to existing devices, and has shown better results. The company has completed a first-in-human trial and is preparing for its large scale US pivotal clinical trials.
This is a hands-on position with responsibility for all PMA regulatory filings. The regulatory expert in this key role will be the primary contact for communication with FDA on Regulatory issues. He or she will work with experienced colleagues in Clinical Research, Engineering, and QA to organize, write, submit, and manage all components of a modular PMA, and will work closely with the CMO and VP of Clinical & Regulatory Affairs to ensure accuracy of data, statistics, and submissions. As needed, they will help to develop regulatory strategies for US and OUS markets.
- Develop and implement regulatory strategies.
- Personally prepare technical documentation to support global regulatory approvals.
- Serve as representative for product regulatory and safety issues to agencies.
- Provide regulatory input to product lifecycle planning.
- Monitor the impact of changing regulations on submission strategies, and update internal stakeholders.
- Ensure compliance with product post-marketing approval requirements.
- Review and approve labeling to ensure compliance with regulations and company policy.
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Review, approve, and help develop preclinical and clinical documentation for submissions.
- Maintain annual licenses, registrations, listings information.
- A minimum of 15 years of medical device Regulatory Affairs experience, including PMAs.
- Mastery and experience with Class 3 medical device requirements, demonstrated by history of successful PMA submissions.
- Regulatory knowledge must include pre-clinical testing and manufacturing requirements.
- MS or BS degree in a technical discipline (eg biology, chemistry, engineering).
- RAPS Regulatory Affairs Certification preferred.
- Good organization and writing skills.
- Good communication with all levels of the company and FDA.
- Knowledge of medical product design control and manufacturing quality system principles and practices.