Regulatory Affairs Manager - Orthopedics

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. As a manager within the Regulatory Affairs organization, you will play a critical role in strategic planning and shaping global regulatory strategies that support innovation and patient outcomes. This is an opportunity to lead, influence and collaborate across a global organization while guiding a talented team through complex regulatory landscapes. If you are motivated by impact, leadership and the challenge of bringing life changing orthopedic technologies to market, this role offers the scope to grow and make a real difference. What will you be doing? Leading and developing a team of project managers and regulatory professionals, providing coaching, guidance and direction while fostering a positive and inclusive team culture Developing and executing strategic global regulatory plans for new product development, market expansion and sustaining activities across the orthopedic device portfolio Acting as a project management and regulatory subject matter expert, engaging proactively with global regulatory authorities and supporting inspections, audits and submissions Overseeing global regulatory submissions including 510(k), PMA, MDR Technical Files, Annual Reports and international registrations Partnering closely with cross functional stakeholders to translate regional regulatory requirements into clear project deliverables Supporting regulatory activities related to mergers, acquisitions and portfolio expansion initiatives Ensuring ongoing compliance by maintaining deep knowledge of global regulations, standards, guidance documents and internal quality system processes Building the project management sub-organization team for the Orthopedic Regulatory Affairs Organization What will you need to be successful? A Bachelor’s degree in engineering, biomedical, clinical, medical or scientific discipline A minimum of 7 years of combined regulatory affairs and project management experience within the medical device industry, with orthopedic experience preferred Proven experience developing and implementing global regulatory strategies across US and international markets Strong knowledge of US and EU regulatory requirements and experience authoring regulatory submissions Demonstrated leadership capability, either through direct people management or matrixed project leadership RAC certification preferred but not required 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 (). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, 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 Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more! We anticipate the application window for this opening to close on 06.30.2026 The anticipated base compensation range for this position is $96,500.00 - $167,500.00 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. #LI-SB2 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. Stay connected by joining our Talent Community . We're more than just a company - we're a community! Follow us on L inkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.