Regulatory Affairs Specialist

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

Are you motivated by navigating complex regulatory landscapes and helping innovative medical technologies reach patients worldwide? As a Regulatory Affairs Specialist, you will play a key role in supporting global regulatory submissions and maintaining compliance across markets. This is an exciting opportunity to work in a collaborative, fast paced environment where your expertise directly supports successful product launches.

What will you be doing?

• Preparing global regulatory submissions including US 510(k) and EU technical documentation for new and modified medical devices

• Partnering closely with cross functional project teams to develop regulatory strategies that support product launch timelines

• Supporting international regulatory submissions in collaboration with regional regulatory colleagues

• Maintaining up to date knowledge of global regulations, standards, guidance documents and country specific requirements

• Completing regulatory change assessments for design, labeling and manufacturing changes to ensure ongoing compliance

• Supporting internal and regulatory authority audits and engaging directly with regulatory agencies when required

• Reviewing product labeling and contributing to the development and maintenance of regulatory SOPs

What will you need to be successful?

• Bachelor's degree or equivalent experience in a scientific or technical discipline

• Minimum of 2 years of regulatory affairs experience within the medical device industry

• Working knowledge of global medical device regulations, standards and guidance

• Strong communication and technical writing skills with the ability to collaborate across diverse teams

• A proactive, analytical mindset with the ability to manage multiple priorities in a fast paced environment

**This position does not offer visa sponsorship now or in the future**

We anticipate the application window for this opening to close on 05.14.2026.

The anticipated base compensation range for this position is $74,250 - $128,750 USD annually.

The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

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 (https://www.smith-nephew.com/).

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

• Work/Life Balance: Flexible Personal/Vacation Time Off, 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

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

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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.