Regulatory Affairs Manager - Orthopedics

Smith+Nephew•Minneapolis, MN

5d•$96,500 - $167,500•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

RAC certification preferred but not required

Responsibilities

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