Regulatory Affairs Specialist (Memphis, TN)

Regulatory Affairs Specialist

At Smith+Nephew we design and manufacture technology that takes the limits off living.

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?

• 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.

What will you need to be successful?

Education : Bachelor's or Master's degree in Regulatory Affairs or closely related field. Will also consider applicants with 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.

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

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%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more about Employee Inclusion Groups on our website.

Other reasons why you will love it here!

Your Future : 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

Work / Life Balance : PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

Your Wellbeing : Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

Flexibility : Hybrid Work Model (For most professional roles)

Training : Hands-On, Team-Customized, Mentorship

Extra Perks : Discounts on fitness clubs, travel and more

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.