Compliance & Regulatory Specialist
| Company | SeekWell |
|---|---|
| Location | Draper, UT, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | |
| Experience Level | Senior |
Requirements
- 5+ years of experience in regulatory compliance and quality assurance for healthcare devices or medical technology.
- Strong knowledge of ISO 13485, ISO 27001/2, FDA QMS, and regulatory submission processes.
- Hands-on experience with FDA submissions and audits.
- Ability to translate complex regulations into actionable compliance strategies.
- Excellent problem-solving and communication skills to guide teams through regulatory requirements.
Responsibilities
- Ensure compliance with ISO 13485 (Medical Device QMS) and ISO 27001/2 (Information Security Management) standards.
- Develop and maintain FDA-compliant Quality Management System (QMS) processes and documentation.
- Support and potentially lead and manage FDA regulatory submissions, ensuring timely and accurate filings.
- Collaborate with product, engineering, and security teams to integrate compliance into product development.
- Provide expert guidance on regulatory and compliance-related inquiries.
- Conduct internal audits, risk assessments, and gap analyses to maintain and improve compliance.
- Stay updated on regulatory changes and proactively implement necessary updates to policies and procedures.
- Work with external regulatory bodies, auditors, and certification agencies as needed.
Preferred Qualifications
- Experience with risk management and information security best practices is a plus.