QA/RA Director - Class III, Structural Heart

Are you keen to take part in cutting edge technology?

Metric Search is currently partnered with an exciting start-up company that develops solutions for structural heart diseases through catheter-based procedures. With trials running in the US and Europe, the company is entering an exciting stage of their growth.

The start-up are now looking for an experienced Director of Quality and Regulatory to join their dynamic and exciting team! In the role, you'll be responsible for developing and managing the implementation and execution of Quality System and regulatory strategies. You'll also ensure effective planning and execution of related workflows throughout the product life cycle (i.e., development, validation, commercial release, distribution and ongoing commercial support).

YOU MUST BE LOCATED in or near Pennsylvania state (other states including New Jersey, New York, Delaware, Maryland, Ohio or West Virginia will also be considered depending on your location).

About the Company

The company has developed ground-breaking technology that helps treat patients with Tricuspid Regurgitation
Successfully completed in-human use of their Tricuspid device
Well funded by numerous investors

The Ideal Candidate

Knowledge of global Quality System regulations, standards and guidance documents, as well as global medical device regulations, standards and guidance documents for implantable medical devices
7+ years of Quality /Quality System, and 5+ years of medical device Regulatory Affairs experience in class III medical devices
Experience working with international and U.S. regulatory bodies
Managerial experience across Quality and or Regulatory Team

What the role offers

A supportive and dynamic work environment, with close, collaborative team
Market competitive compensation package
Hybrid role, requiring you to be onsite a couple days a week
Plenty of room for career development and progression
Managerial role
Senior role, reporting directly to COO, with the expectation for you to build out the team
Opportunity to onboard a company at its peak time of growth
Opportunity to contribute to a pioneering start-up at the forefront of healthcare innovation

If interested, click apply, send me a direct message or reach out via email:

📧Caitlin.James@metric-search.com

Due to the amount of expected applicant, only those who have the relevant background and experience will be contacted.

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Director of Quality and Regulatory