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.
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Responsible for preparing Canadian applications to obtain approval to commercially distribute product.
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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.
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Prepare routine regulatory correspondence and assure submission to government agencies in support of marketed products.
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Participate in project development teams and review plans, reports, risk management, and design reviews associated with product and process projects.
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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).
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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.
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Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations.
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Reviews complaints/adverse events for submission of MDRs and Vigilance Reports.
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Review and approve advertising/marketing material, and product labeling to ensure compliance with applicable regulatory requirements.
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Participates in internal/external audits and responses to support audit findings or other respective actions related to such audits.
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Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.
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Coordinate product correction and removals (recalls, market withdrawals, and stock retrievals) per procedures and applicable regulations.
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Maintain Unique Device Identifier (UDI) activities for implementation/compliance.
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Maintain regulatory registrations and product listings.
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Assist in negotiations with the FDA or other regulatory agencies.
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All other reasonable duties, as assigned.
Qualifications and Experience:
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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;
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Expert level knowledge of FDA 21 CFR Part 820 and 510(k) submission requirements;
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Authoring of 510(k) submissions;
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Experience and knowledge of Canadian Medical Device Regulations, MDSAP, and ISO Standards;
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Experience with ToC format for Canadian applications, preferred;
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Ability to work in a fast paced, collaborative team environment
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Ability to handle multiple projects and coordinate with cross functional teams;
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Ability to comfortably and effectively confront difficult situations and issues in a timely and appropriate manner while providing a solution;
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Ability to recommend technical solutions;
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Ability to specify regulatory requirements for products;
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General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
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Ability to work independently under general guidelines and supervision from the RA Manager.
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Self-starter and highly motivated.
