Regulatory Affairs Manager - Orthopedics
Smith+Nephew
Summary
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.
Job description
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
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
- Orthopedic experience preferred
- Proven experience developing and implementing global regulatory strategies across US and international markets
- Strong knowledge of US and EU regulatory requirements
- Experience authoring regulatory submissions
- Demonstrated leadership capability through direct people management or matrixed project leadership
- RAC certification preferred but not required
Benefits
- 401(k) Matching
- 401(k) Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible Time Off
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental & Vision
- Health Savings Account
- Employee Assistance Program
- Parental Leave
- Fertility & Adoption Assistance
- Hybrid Work Model
- Fitness Club Discounts
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.