Head of Regulatory and Quality
As Head of Quality & Regulatory Strategy, you will have a critical role in managing and overseeing Bodyport’s key interactions with regulatory agencies, including the FDA. You will help guide Bodyport’s regulatory strategy and lead the preparation of 510(k) and De Novo FDA submissions. You will provide strategic insight and guidance on clinical trial design to help achieve regulatory clearance and demonstrate the value of Bodyport’s novel technology. You will help build and manage Bodyport’s quality management system and ensure that all team members are effectively and efficiently trained to ISO 13485 and 21 CFR 820 requirements. Most importantly, you will help champion a culture of quality at Bodyport and ensure that it is a critical part of everything we do at Bodyport.
Your role at Bodyport:
- Lead the development of the regulatory and quality strategy at Bodyport
- Prepare Bodyport’s regulatory submissions to the FDA
- Develop and maintain Bodyport’s quality management system (QMS) and associated documentation
- Provide regulatory guidance to clinical and engineering teams
- Audit key suppliers and manufacturing partners
- Build and manage employee training system to ensure compliance and quality goals are met
- Maintain awareness of latest regulatory and policy changes
- Help manage complaints and Medical Device Reporting (MDR)
You'd be a great fit if you have:
- 5+ years experience in regulatory role
- Previously drafted, filed , and receive clearance or approval for an FDA submission (510(k), IDE, De Novo, PMA)
- Prior experience implementing and managing an ISO13485 and cGMP quality system
- Understanding of FDA medical device design requirements (21 CFR 820.30)
- Solid background in regulatory requirements for medical software development (IEC 62304) including cybersecurity
- Familiarity with data privacy laws including HIPAA and GDPR
- An ability to organize, prioritize and work effectively in a constantly changing environment
- Strong verbal and written communication skills
We want you to know:
You can be a great candidate even if you don't fit everything we've described above. You can also have important skills we haven't thought of. If that's you, don't hesitate to apply and tell us about yourself (especially in your cover letter - this is where you can really state your case).
We are committed to diversity and building an equitable and inclusive environment for people of all backgrounds and experiences, and we're taking steps to meet that commitment. We especially encourage members of traditionally underrepresented communities to apply, including women, people of color, LGBTQ people, veterans, and people with disabilities.