Quality Systems & Regulatory Affairs Specialist II, Digital Health
Boston, MAFull-TimeMid-levelOther
RESPONSIBILITIES:
- Support and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change notifications, and post-market reports.
- Interpret international regulatory and quality requirements for medical devices across key markets.
- Create detailed regulatory and quality deliverables for global distribution of medical devices in countries such as Canada, Japan, EU, Brazil, and others.
- Prepare regulatory submissions for medical devices and maintain regulatory clearance throughout the product lifecycle.
- Interface with internal stakeholders such as engineering, product, and clinical teams to ensure regulatory and quality considerations are communicated throughout the product development lifecycle.
- Support internal audits, gap assessments, and procedural updates for compliance with ISO 13485, IEC 62304, EU MDR, and MDSAP requirements.
- Support maintenance and continuous improvement of the quality management system.
- Support regulatory assessments of post-market changes and reportable events.Support and lead internal and external audit activities to maintain QMS certifications.
QUALIFICATIONS:
- Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience.
- At least 4 years of experience in the medical device industry with regulatory submission experience, specifically in Brazil, Mexico, Japan and South Korea.
- Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision.
- Demonstrated history in achieving regulatory market authorization.
- Knowledge and experience with Software as a Medical Device, Cybersecurity, Verification & Validation, and global Digital Health policy. Experience with AI/ML is a plus.
- Demonstrated experience in and working knowledge of medical device regulations and standards (ISO 13485, MDSAP etc).
- Passion for delivering impactful and high-quality products to people.
