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About the job

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.

Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product.

Responsible for preparing Canadian applications to obtain approval to commercially distribute product.

Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.

Prepare routine regulatory correspondence and assure submission to government agencies in support of marketed products.

Participate in project development teams and review plans, reports, risk management, and design reviews associated with product and process projects.

Assess necessity for submitting a 510(k) application by preparing regulatory assessments for manufacturing, line extensions, design changes, and validation activities. Prepare internal letter to File (US) for changes that do not require a 510(k) submission, and assess also for Canadian impact (i.e. application amendments).

Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects.

Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations.

Reviews complaints/adverse events for submission of MDRs and Vigilance Reports.

Review and approve advertising/marketing material, and product labeling to ensure compliance with applicable regulatory requirements.

Participates in internal/external audits and responses to support audit findings or other respective actions related to such audits.

Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.

Coordinate product correction and removals (recalls, market withdrawals, and stock retrievals) per procedures and applicable regulations.

Maintain Unique Device Identifier (UDI) activities for implementation/compliance.

Maintain regulatory registrations and product listings.

Assist in negotiations with the FDA or other regulatory agencies.

All other reasonable duties, as assigned.

Qualifications and Experience:

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;

Experience with ToC format for Canadian applications, preferred;

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.