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 (https://www.smith-nephew.com/).
- 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 08.21.2026
Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by local and state policies.
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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.