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Eliminating heart disease with sensors and science.

Head of Regulatory and Quality

$100k – $180k • 0.05% – 0.5%
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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 partnersBuild 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)
- Provide regulatory and compliance input to inform the development of clinical trials and pilots

You'd be a great fit if you have:
- 10+ years experience in regulatory role
- Previously drafted, filed , and receive clearance or approval for at least 2 submissions to FDA (510(k), IDE, De Novo, PMA)
- Preference candidates with prior experience working directly with cardiovascular division of FDA
- Prior experience implementing and managing an ISO13485 and cGMP quality system
- Deep 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
- Must be able to organize, prioritize and work effectively in a constantly changing environment
- Strong verbal and written communication skills

Apply here: jobs.lever.co/bodyport/23418352-0dcc-4d03-9a02-659d9d68b6f4

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