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

What will you be doing?

The Senior Regulatory Affairs Specialist is responsible for preparing and supporting US and International regulatory submissions and regulatory strategies. The incumbent possesses knowledge of regulatory requirements gained through experience and is able to perform the essential duties and responsibilities with some direct supervision.

What will you need to be successful?

• Prepare global regulatory submissions (such as 510(k), PMA, MDR Technical Files, Annual Reports, etc.) for the Ascension product portfolio.

• This includes submissions, notifications, etc. for new devices, modified devices and any other changes requiring submission, registration updates, etc.

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

• Maintain computer database to insure only cleared products are released for sale. Maintain UDI database systems per assigned responsibilities.

• Maintain regulatory informational systems for submission/regulatory impact assessment tracking and metrics.

• Review and approve engineering change requests/notifications for design, manufacturing and labelling changes to ensure compliance with FDA and international government regulations.

• Develop instructions for use content with support from core functional leads. Review IFU's, Surgical Techniques and promotional materials to ensure compliance with FDA and international requirements. Support internal and external audits, as directed by management. Manage/lead regulatory-driven project, as directed by management.

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

• Development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary. Support with departmental infrastructure development and maintenance

• Education: Bachelor's degree preferably in a clinical, medical, or scientific/technical discipline. Biomedical engineering degree preferred but not required.

• Experience: 5- 8 years of regulatory experience in the medical device industry required or direct work experience in a regulated industry or like discipline; Orthopedic device experience desired

• Travel Requirements: up to 10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about 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

The anticipated base compensation range for this position is $120,000.00 - $140,000.00 USD annually and the compensation offered will depend on the candidate's qualifications. You may also be entitled to receive bonus and benefits, which may include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by local and state policies.

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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.