Sr. Regulatory Affairs Specialist - Relocation Assistance Provided

Innovative Health•Scottsdale, AZ

About The Position

The Sr. Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrations to regulatory agencies. This role involves managing and preparing 510(k) submissions to obtain FDA clearance and Canadian applications for commercial distribution approval. The specialist will review and approve test protocols/reports and other documentation for regulatory submissions, prepare routine regulatory correspondence, and participate in project development teams. Key responsibilities include assessing the necessity for 510(k) applications, preparing internal letters to file, maintaining knowledge of current regulations, developing regulatory procedures, reviewing complaints/adverse events for MDRs and Vigilance Reports, approving marketing materials and labeling, participating in audits, reviewing engineering change orders and CAPA documentation, coordinating product corrections and removals, maintaining UDI activities, managing regulatory registrations, and assisting in negotiations with regulatory agencies.

Requirements

Bachelor's Degree in Life Science is preferred.
Minimum of 8 years Regulatory experience in the Medical Device industry.
Expert level knowledge of FDA 21 CFR Part 820 and 510(k) submission requirements.
Authoring of 510(k) submissions.
Experience and knowledge of Canadian Medical Device Regulations, MDSAP, and ISO Standards.
Ability to work in a fast paced, collaborative team environment.
Ability to handle multiple projects and coordinate with cross functional teams.
Ability to comfortably and effectively confront difficult situations and issues in a timely and appropriate manner while providing a solution.
Ability to recommend technical solutions.
Ability to specify regulatory requirements for products.
General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
Ability to work independently under general guidelines and supervision from the RA Manager.
Self-starter and highly motivated.

Nice To Haves

Experience with ToC format for Canadian applications.

Responsibilities

Preparing and submitting documentation for FDA 510(k)s, periodic updates, Canadian applications, and registrations.
Managing and preparing 510(k) submissions for FDA clearance.
Preparing Canadian applications for commercial distribution approval.
Reviewing and approving test protocols/reports and other documentation for regulatory submissions.
Preparing routine regulatory correspondence and ensuring submission to government agencies.
Participating in project development teams and reviewing plans, reports, risk management, and design reviews.
Assessing the necessity for 510(k) applications and preparing regulatory assessments.
Preparing internal letter to File (US) for changes not requiring a 510(k) submission and assessing Canadian impact.
Maintaining and disseminating current knowledge of regulations, standards, and guidance documents.
Developing and maintaining regulatory procedures and policies.
Reviewing complaints/adverse events for submission of MDRs and Vigilance Reports.
Reviewing and approving advertising/marketing material and product labeling.
Participating in internal/external audits and responding to audit findings.
Conducting regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.
Coordinating product correction and removals (recalls, market withdrawals, and stock retrievals).
Maintaining Unique Device Identifier (UDI) activities.
Maintaining regulatory registrations and product listings.
Assisting in negotiations with the FDA or other regulatory agencies.
Performing other reasonable duties as assigned.