Meta AR/VR Job | Head of Medical Devices Regulatory Affairs
Job（岗位）: Head of Medical Devices Regulatory Affairs
Type（岗位类型）: Business Development +3 more
Citys（岗位城市）: Sunnyvale, CA +3 locations
Date（发布日期）: 2024-8-21
Summary（岗位介绍）
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).
Qualifications（岗位要求）
Bachelor’s Degree in Biomedical Engineering or other Technical Science field
12+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences)
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
Experience authoring technical reports, business correspondence and standard operating procedures
Proven communication skills. Experience presenting clearly and persuasively to technical, non-technical, and regulator audiences
Proven leadership qualities in developing top talent, championing new initiatives in a large organization, and representing the organization to outside regulatory agencies
Description（岗位职责）
Lead project teams for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globe
Ensure products are brought to market on time, and sustained throughout life cycle via compliant, innovative regulatory strategies
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
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
Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System
Establish growth plans and hire excellent talent to the organization that intelligently scales with the business needs
Review and approve marketing, advertising, promotional items and labeling for regulatory compliance
Additional Requirements（额外要求）
Master’s Degree in Regulatory Affairs
RAC Certification
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.)
Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
Direct to consumer health wearables product experience
Experience working in fast moving, high tech companies
