Quality Systems & Regulatory Affairs Specialist, Digital Health

Posted 2 Days Ago
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Boston, MA
Hybrid
Mid level
Fitness • Hardware • Healthtech • Sports • Wearables
The Role
As a Quality Systems & Regulatory Affairs Specialist at WHOOP, you'll execute regulatory strategies and support QMS maintenance for Software as a Medical Device (SAMD) products in a dynamic environment.
Summary Generated by Built In

At WHOOP, we're on a mission to unlock human performance and health span. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives. WHOOP is looking for a Regulatory Affairs Specialist to be a core member of the Digital Health team at WHOOP. 


As the Quality Systems & Regulatory Affairs Specialist, you will execute regulatory strategy and support QMS maintenance deliverables for WHOOP SAMDs in a dynamic and agile environment. In an innovative and evolving space, you will need to bring creative problem-solving with an ability to adapt to a changing landscape.

RESPONSIBILITIES:

  • Interprets international regulatory and quality requirements for medical devices. 
  • Creates detailed regulatory and quality deliverables for international distribution of medical devices in countries such as Canada, Japan, EU, Brazil, etc.
  • Prepares regulatory submissions for medical devices and maintains regulatory clearance through the product lifecycle.
  • Interfaces with internal stakeholders such as engineering, product, and clinical to ensure regulatory and quality considerations are communicated throughout the product development lifecycle. 
  • Supports internal audits, gap assessments and updates to procedures for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements.
  • Supports maintenance of the quality management system. 
  • Supports regulatory assessments of post-market changes and reportable events.
  • Supports and leads 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.

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The Company
HQ: Boston, MA
500 Employees
Hybrid Workplace
Year Founded: 2012

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.

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WHOOP Offices

Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Typical time on-site: Not Specified
HQBoston, MA
Limerick, Limerick, V94 4D83 Ireland
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