Regulatory Affairs Manager - Orthopedics

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