Regulatory Affairs Manager • Mid-Level

Who you are

You have a strong background in regulatory affairs, particularly in the healthcare or medical device sectors, with experience in new product development. Your understanding of regulatory requirements and standards allows you to navigate complex compliance landscapes effectively. You are detail-oriented and possess excellent analytical skills, enabling you to assess risks and benefits associated with product development. You thrive in collaborative environments and can communicate effectively with cross-functional teams, including engineering, clinical research, and business development. Your proactive approach to problem-solving ensures that you can anticipate challenges and develop strategies to address them. You are committed to improving patient outcomes and understand the importance of aligning product development with regulatory expectations.

What you'll do

In this role, you will lead the regulatory strategy for new product development at Axogen, ensuring that all products meet necessary regulatory requirements before market introduction. You will collaborate closely with engineering and clinical teams to define product specifications and guide the development process. Your responsibilities will include preparing and submitting regulatory documentation, conducting risk assessments, and maintaining compliance with FDA and other regulatory bodies. You will also monitor changes in regulations and industry standards, adapting strategies as necessary to ensure ongoing compliance. Additionally, you will play a key role in training and educating team members about regulatory processes and requirements, fostering a culture of compliance within the organization.

What we offer

Axogen provides a supportive and engaging work environment that values professional growth and development. You will have access to a comprehensive benefits package effective from your first day, including educational assistance and a matching 401(k) retirement plan. Our company culture emphasizes teamwork and collaboration, with a focus on making a meaningful impact on patients' lives. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds.