Senior Regulatory Affairs Specialist

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

Are you a regulatory affairs professional who enjoys working at the intersection of innovation, compliance, and patient impact? Join our growing Sports Medicine franchise and play a key role in supporting life changing medical technologies used by patients around the world. This is an opportunity to work collaboratively with global teams while shaping regulatory strategy across the full product lifecycle.

What will you be doing?

• Developing and executing global regulatory strategies for new and modified medical devices

• Preparing and managing regulatory submissions to obtain and maintain global market approvals

• Providing regulatory guidance to cross functional teams across product development, manufacturing, and compliance activities

• Assessing product and manufacturing changes to ensure continued regulatory compliance throughout the product lifecycle

• Acting as a company representative with global regulatory agencies, building and maintaining strong professional relationships

• Supporting regulatory audits, advocacy initiatives, and regulatory intelligence activities

• Developing and maintaining regulatory SOPs and providing training and mentoring to colleagues

What will you need to be successful?

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

• 5 or more years of Regulatory Affairs or related experience within the medical device industry

• Proven experience managing FDA 510(k) submissions and EU MDR filings

• Strong understanding of global regulatory requirements and medical device development processes

• Excellent written and verbal communication skills, including technical writing

• RAPS certification is an advantage

Theanticipatedbase compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. You will be entitled to receive bonus and benefits, which 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.

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.