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The Quality Systems & Regulatory Affairs Specialist will execute regulatory strategies and maintain QMS for medical devices, ensuring compliance with international standards through collaboration and innovative problem-solving.
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 II to be a core member of the Digital Health team at WHOOP.
As the Regulatory Affairs & Quality Systems Specialist II, 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:
- 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.
This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success.
The U.S. base salary range for this full-time position is $105,000 - $135,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.
In addition to the base salary, the successful candidate will also receive benefits and a generous equity package..
These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.
Learn more about WHOOP.
Top Skills
AI
Cybersecurity
Digital Health Policy
Iec 62304
Iso 13485
Mdsap
Ml
Regulatory Compliance
Software As A Medical Device
Verification & Validation
WHOOP Boston, Massachusetts, USA Office
1 Kenmore Sq, Boston, MA, United States, 02215
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