Regulatory Affairs Specialist - Multiple Locations

About the position Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This role is based in Memphis Tennessee and may also be in Andover Massachusetts, Fort Worth Texas or Pittsburgh Pennsylvania. This position does not offer visa sponsorship now or in the future Are you passionate about navigating regulatory landscapes? Do you thrive in fast-paced environments? We're looking for a Regulatory Affairs Specialist to join our team and drive regulatory strategies for our cutting-edge products. If you're ready to make an impact, apply now! What will you be doing? You will contribute to bringing orthopaedic innovations to patients by leading regulatory strategy and execution across global markets.

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.

Requirements

• Bachelor’s degree, preferably in engineering, clinical, medical or scientific or technical discipline; RAPS certification or a Master’s degree in Regulatory Affairs is an advantage.
• A minimum of 2 years of Regulatory Affairs experience or equivalent within the medical device industry.
• Knowledge of current US and EU regulations is essential.
• Orthopedic device experience desired
• 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
• Travel Requirements: 0-5%

Nice-to-haves

• RAPS certification or a Master’s degree in Regulatory Affairs is an advantage.
• Orthopedic device experience desired

Benefits

• competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.
• 401k Matching Program
• 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Discounts on fitness clubs, travel and more!

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