Regulatory Affairs Manager - Orthopedics

1d1 day ago

Smith+Nephew

US · Full-time · $96,500 – $167,500

About this role

As a manager within the Regulatory Affairs organization at Smith+Nephew, you will play a critical role in strategic planning and shaping global regulatory strategies that support innovation and patient outcomes. This position offers the opportunity to lead, influence and collaborate across a global organization while guiding a talented team through complex regulatory landscapes.

You will develop and execute strategic global regulatory plans for new product development, market expansion and sustaining activities across the orthopedic device portfolio. The role involves overseeing submissions including 510(k), PMA, MDR Technical Files and international registrations while engaging with global regulatory authorities.

You will lead and develop a team of project managers and regulatory professionals, providing coaching and fostering a positive team culture. Close partnership with cross-functional stakeholders will translate regional requirements into clear project deliverables while supporting mergers, acquisitions and portfolio initiatives.

This role provides scope to grow and make a real difference by bringing life-changing orthopedic technologies to market. You will build the project management sub-organization for the Orthopedic Regulatory Affairs team while maintaining deep knowledge of global regulations and internal quality systems.

Requirements

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, 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

Responsibilities

Lead and develop a team of project managers and regulatory professionals, providing coaching, guidance and direction while fostering a positive and inclusive team culture
Develop and execute strategic global regulatory plans for new product development, market expansion and sustaining activities across the orthopedic device portfolio
Act as a project management and regulatory subject matter expert, engaging proactively with global regulatory authorities and supporting inspections, audits and submissions
Oversee global regulatory submissions including 510(k), PMA, MDR Technical Files, Annual Reports and international registrations
Partner closely with cross-functional stakeholders to translate regional regulatory requirements into clear project deliverables
Support regulatory activities related to mergers, acquisitions and portfolio expansion initiatives
Ensure ongoing compliance by maintaining deep knowledge of global regulations, standards, guidance documents and internal quality system processes
Build the project management sub-organization team for the Orthopedic Regulatory Affairs Organization

Benefits

401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Hybrid Work Model
Hands-On, Team-Customized, Mentorship training
Discounts on fitness clubs, travel and more