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Smith+Nephew · 2 days ago

Regulatory Affairs Specialist (Memphis, TN)

Memphis, TN

Full-time

Hybrid

Entry, Mid Level

2+ years exp

Smith+Nephew is a company that designs and manufactures technology aimed at enhancing quality of life. They are seeking a Regulatory Affairs Specialist to manage regulatory strategies for their orthopedic products, ensuring compliance with various regulatory bodies and preparing necessary documentation for product submissions.

Medical Device

Comp. & Benefits

Responsibilities

Prepare global regulatory submissions (such as 510(k), PMA, MDR Technical Files, Annual Reports, etc.) for the orthopedic reconstruction device product portfolio.  This includes submissions, notifications, etc. for new devices, modified devices and any other changes requiring submission, registration updates, etc

Support business critical sustaining activities for the legacy orthopedic product portfolio, including regulatory impact assessments and associated re-registrations for manufacturing transfers, processing changes, and design modifications

Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets

Communicate with FDA and other regulatory bodies regarding submissions

Support cross-functional projects through the provision of regulatory submission/compliance strategy document, regulatory inputs, and documentation reviews (CER, IOVV, Risk Management Documentation, etc.)

Support technical file and quality audits

Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements

Review and approve change requests for design, manufacturing and labelling changes to ensure compliance with FDA and international government regulations.  Complete associated regulatory impact assessments and execute applicable re-registrations and change notifications

Review package inserts (IFU's), Surgical Techniques and promotional materials to ensure compliance with regulations

Support International Registrations for the Ortho product portfolio for all regions.  Maintain, update, organize, etc. the existing regulatory files, as directed by management

Qualification

Regulatory submissionsUSEU regulationsMedical device experienceRegulatory impact assessmentsTechnical writingAnalytical skillsMicrosoft OfficeCommunication skills

Required

Bachelor's or Master's degree in Regulatory Affairs or closely related field

BA or BS in Business Administration, Life Science, nursing, medical technology or related field with 3 or more years of prior work experience in the regulated medical industry

Minimum of 2 years of relevant regulatory experience in the medical device industry is required

Knowledge of current US and EU regulations is essential

Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents

Ability to respond to inquiries from regulatory agencies

Ability to write detailed technical regulatory submissions, reports and business correspondence

Ability to effectively present information to other employees, management and regulatory agencies

Ability to use Microsoft Outlook, TEAMs, Word, Excel, PowerPoint