Petros Inc has been retained by a startup medical device company in the cardiology space to recruit a seasoned Director/Sr Director of Quality & Regulatory for a Class III, active implantable device. Candidates MUST HAVE hands-on experience bringing a Class III implantable device from development to commercialization.
To be considered, the candidates will need to have:
- 10+ years’ experience working hands-on, “in the trenches”, leading teams and strategy in Medical Device Quality Assurance and Quality Management.
- Deep knowledge of Regulatory and QMS regulations.
- Experience with regulatory filings to include 510(k) and PMA.
- FDA and CE Mark submissions.
- Experience bringing Class III, active implantable mechanical, electrical and software devices through development to commercialization.
- Design Assurance / hands-on engineering background highly preferred.
You will develop, implement, and maintain the QMS, and work closely with product development and manufacturing teams to ensure adherence to QA procedures. The focus will be developing a comprehensive strategy to support and drive the company to commercialization of a Class III product.
This position reports to the President and will have hands-on responsibilities for all issues related to Quality which include: QMS, design control, risk management, process validation, supplier evaluation, regulatory compliance, risk management, CAPA, management reviews. Candidates must have comprehensive knowledge and experience in all areas of Quality.
This is a hybrid role with travel around 50% as the engineering and manufacturing teams are currently based in Michigan. Travel will be flexible as systems and relationships are established.
This is a GREAT opportunity to have the autonomy to create and implement systems and strategies, work with a small, highly motivated team and be in on the ground floor where your work will have significant impact on the success of the company. Reach out and we can discuss what you are looking for at this point in your career!