Regulatory Affairs Manager - Orthopedics
Salary$97k – $168k
LocationUS - Field
Work modehybrid
Typefull-time
SenioritySenior
Experience7+ yrs
DepartmentRegulatory Affairs
Company size10,000+ people
PostedOct 5, 2026 · 1w ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
Bachelor’s degree in engineering, biomedical, clinical, medical or scientific discipline
Minimum of 7 years of combined regulatory affairs and project management experience within the medical device industry
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
Orthopedic experience preferred
RAC certification preferred but not required
Benefits
Health insurance
Dental
Vision
401(k)
Tuition reimbursement
Stock purchase plan
Unlimited PTO
Flexible PTO
Paid holidays
Flex holidays
Paid community service
Employee assistance program
Parental leave
Fertility assistance
Adoption assistance
Health savings account
Remote stipend
About the company
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
About the role
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?
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Leading and developing a team of project managers and regulatory professionals, providing coaching, guidance and direction while fostering a positive and inclusive team culture
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Developing and executing strategic global regulatory plans for new product development, market expansion and sustaining activities across the orthopedic device portfolio
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Acting as a project management and regulatory subject matter expert, engaging proactively with global regulatory authorities and supporting inspections, audits and submissions
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Overseeing global regulatory submissions including 510(k), PMA, MDR Technical Files, Annual Reports and international registrations
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Partnering closely with cross functional stakeholders to translate regional regulatory requirements into clear project deliverables
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Supporting regulatory activities related to mergers, acquisitions and portfolio expansion initiatives
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Ensuring ongoing compliance by maintaining deep knowledge of global regulations, standards, guidance documents and internal quality system processes
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Building the project management sub-organization team for the Orthopedic Regulatory Affairs Organization
What will you need to be successful?
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A Bachelor’s degree in engineering, biomedical, clinical, medical or scientific discipline
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A minimum of 7 years of combined regulatory affairs and project management experience within the medical device industry, with orthopedic experience preferred
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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.
Benefits
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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/).
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Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
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Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
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Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
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Flexibility: Hybrid Work Model (For most professional roles)
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Training: Hands-On, Team-Customized, Mentorship
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Extra Perks: Discounts on fitness clubs, travel and more!
Hiring process
We anticipate the application window for this opening to close on 10.16.2026
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.
Legal
Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by local and state policies.
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.
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