Sr. Regulatory Affairs Specialist - Relocation Assistance Provided

Innovative Health LLC•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 for FDA clearance, preparing Canadian applications for commercial distribution approval, and reviewing/approving test protocols and reports. The specialist will also prepare routine regulatory correspondence, participate in project development teams, and assess the necessity for 510(k) applications. Additionally, they will maintain knowledge of current regulations, develop regulatory procedures, review complaints and adverse events, approve advertising/marketing materials, participate in audits, and coordinate product corrections and removals. Maintaining Unique Device Identifier (UDI) activities and regulatory registrations are also key responsibilities, along with assisting in negotiations with regulatory agencies.

Requirements

Bachelor's Degree in Life Science is preferred with a minimum of 8 years Regulatory experience in the Medical Device industry; or equivalent combination of education and experience.
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, preferred.

Responsibilities

Preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrations to regulatory agencies.
Managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product.
Preparing Canadian applications to obtain approval to commercially distribute product.
Reviewing and approving test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
Preparing routine regulatory correspondence and assuring submission to government agencies in support of marketed products.
Participating in project development teams and reviewing plans, reports, risk management, and design reviews associated with product and process projects.
Assessing necessity for submitting a 510(k) application by preparing regulatory assessments for manufacturing, line extensions, design changes, and validation activities.
Preparing internal letter to File (US) for changes that do not require a 510(k) submission, and assessing also for Canadian impact (i.e. application amendments).
Maintaining and disseminating current knowledge base of existing regulations, standards, or guidance documents and proactively seeking and finding information to help resolve questions related to assigned projects.
Developing and maintaining regulatory procedures and policies to ensure compliance to applicable regulations.
Reviewing complaints/adverse events for submission of MDRs and Vigilance Reports.
Reviewing and approving advertising/marketing material, and product labeling to ensure compliance with applicable regulatory requirements.
Participating in internal/external audits and responses to support audit findings or other respective actions related to such audits.
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) per procedures and applicable regulations.
Maintaining Unique Device Identifier (UDI) activities for implementation/compliance.
Maintaining regulatory registrations and product listings.
Assisting in negotiations with the FDA or other regulatory agencies.
Performing all other reasonable duties, as assigned.