Easter Seals Jobs

Summary:

Reality Labs is seeking an experienced medical devices regulatory affairs professional to lead the regulatory strategy and product approvals for novel hardware and software as a medical device products for distribution into many worldwide markets. The ideal candidate is a subject matter expert who can work cross functionally to drive medical devices regulatory goals in an organization that is primarily consumer electronics focused but has a growing medical device portfolio. The ideal candidate will act as the leader for the growing Medical Devices Regulatory Affairs team, be an internal consultant to other functions, and have deep domain experience in electromechanical devices and software as a medical device (SaMD).

Required Skills:

Head of Medical Devices Regulatory Affairs Responsibilities:

1. Lead project teams for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globe

2. Ensure products are brought to market on time, and sustained throughout life cycle via compliant, innovative regulatory strategies

3. Collaborate proactively and establish strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities and other regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid market access to Meta Reality Labs products

4. Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business

5. Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System

6. Establish growth plans and hire excellent talent to the organization that intelligently scales with the business needs

7. Review and approve marketing, advertising, promotional items and labeling for regulatory compliance

Minimum Qualifications:

Minimum Qualifications:

8. Bachelor’s Degree in Biomedical Engineering or other Technical Science field

9. 12+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences)

10. Demonstrated knowledge and experience in the application of the MDD & EU MDR, FDA regulatory approval pathways DeNovo and 510k, and other worldwide regulators in particular for Software as a Medical Device (SaMD) products

11. Experience authoring technical reports, business correspondence and standard operating procedures

12. Proven communication skills. Experience presenting clearly and persuasively to technical, non-technical, and regulator audiences

13. Proven leadership qualities in developing top talent, championing new initiatives in a large organization, and representing the organization to outside regulatory agencies

Preferred Qualifications:

Preferred Qualifications:

14. Master’s Degree in Regulatory Affairs

15. RAC Certification

16. Extensive knowledge of a broad set of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)

17. Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables

18. Direct to consumer health wearables product experience

19. Experience working in fast moving, high tech companies

Public Compensation:

$204,000/year to $281,000/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 accommodations-ext@fb.com.