Regulatory Affairs & Quality Systems Specialist II Digital Health

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.

What We Do

At WHOOP we’re on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives. Our wearable device and performance optimization platform has been adopted by many of the world's greatest athletes and consumers alike.

Why Work With Us

At WHOOP we’re focused on building an inclusive and equitable team with a strong sense of belonging for everyone—increasing representation in every way as our team grows. We believe that our differences are our source of strength—so much so it’s one of our core values.


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