Medical Devices, Regulatory Affairs Specialist

Meta•Redmond, WA

1d•$118,000 - $173,000

About The Position

We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for novel hardware and software as a medical device (SaMD) products for distribution into worldwide markets. You will apply your subject matter expertise in regulatory strategy and approvals to partner with cross-functional teams, enabling the launch of regulated medical devices. This role is within an organization primarily focused on consumer electronics but with an expanding medical device portfolio in wearables and artificial intelligence (AI) products.

Requirements

Bachelor’s Degree in Engineering or other Technical Science field
5+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences)
Demonstrated success 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
Proven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience in an environment that is not medical device native
Demonstrated success in authoring technical reports, business correspondence, regulatory applications, and standard operating procedures

Nice To Haves

Master’s Degree in Regulatory Affairs
Regulatory Affairs Professionals Society Regulatory Affairs Certification Certification
Experience with direct to consumer health wearables product both regulated and wellness
Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables

Responsibilities

Act as the core team member 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, novel 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 cross-functional partnerships between Regulatory Affairs and all key stakeholders including Legal, 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
Review and approve marketing, advertising, promotional items and labeling for regulatory compliance