"Alerted.org

Summary:

As a Regulatory Affairs Lead, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized in the smart wearables and software as a medical device direct to consumer space. You will lead regulatory strategy development, submissions, and approvals for United States and international market access, ensuring alignment with international regulatory requirements (wellness, class 1, and class 2 devices). In collaboration with cross-functional teams, you will work to launch and expand our products in global markets by navigating complex regulatory landscapes and driving successful product registrations.

Required Skills:

Medical Devices, Regulatory Affairs Lead Responsibilities:

1. Develop and implement regulatory strategies for novel and predicate Over-the-Counter software devices to achieve timely product approvals

2. Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions

3. Provide expertise on regulatory requirements and standards (e.g., FCC, IEC, ISO, etc.) to product development teams

4. Monitor and interpret global regulatory trends and provide guidance to internal stakeholders

5. Collaborate with Product Management, Engineering, Quality, and other teams to ensure product compliance throughout the lifecycle

6. Support audits, inspections, and regulatory interactions including direct interface with product reviewers

7. Lead and solve problems and issues that are difficult, complex and undefined, and require detailed information gathering, analysis and investigation

Minimum Qualifications:

Minimum Qualifications:

8. 7+ years of industry experience in medical device regulatory affairs or related industry

9. Experience in global regulatory submissions and product approvals

10. Experience communicating and leading to influence cross-functional teams and management

11. Experience navigating complex regulatory environments and providing strategic guidance

Preferred Qualifications:

Preferred Qualifications:

12. Regulatory Affairs Certification in Medical Devices

13. Experience managing large projects as the subject matter expert for regulatory affairs

14. Experience working on projects exercising considerable latitude in determining deliverables of assignments, with limited oversight from manager

15. Current experience with Software as a Medical Device product submissions as DeNovo, 510k, and EU MDR

Public Compensation:

$143,000/year to $200,000/year + bonus + equity + benefits

**Industry:** Internet

Equal Opportunity:

Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.

Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at [email protected].