Regulatory Affairs Manager (Clinical Focus)

Who you are

You have a strong background in regulatory affairs, particularly within the clinical sector, and understand the complexities of navigating regulatory requirements in healthcare. Your experience includes developing and implementing regulatory strategies that align with business objectives while ensuring compliance with applicable laws and regulations. You are detail-oriented and possess excellent analytical skills, allowing you to assess regulatory risks and develop mitigation strategies effectively. You thrive in collaborative environments and enjoy working closely with cross-functional teams to drive projects forward. Your communication skills are top-notch, enabling you to articulate complex regulatory concepts to diverse stakeholders clearly. You are committed to continuous professional development and staying updated on industry trends and regulatory changes.

Desirable

Experience in the medical device industry or related fields is a plus, as is familiarity with FDA regulations and ISO standards. A background in clinical research or product development can enhance your ability to contribute to the team effectively.

What you'll do

As the Regulatory Affairs Manager at Axogen, you will lead the development and execution of regulatory strategies for clinical products. You will be responsible for preparing and submitting regulatory documents to ensure compliance with FDA and other regulatory bodies. Your role will involve collaborating with product development teams to provide regulatory guidance throughout the product lifecycle, from concept to market launch. You will also monitor regulatory changes and assess their impact on the organization, ensuring that all processes align with current regulations. Additionally, you will conduct training sessions for internal teams on regulatory requirements and best practices, fostering a culture of compliance within the organization. You will play a key role in maintaining relationships with regulatory agencies and responding to inquiries or audits as needed.

What we offer

At Axogen, you will be part of a friendly and open team culture that values unique perspectives and fosters professional growth. We offer a comprehensive benefits package effective on your first day, including educational assistance, a matching 401(k) retirement plan, and paid holidays. You will have the opportunity to work in a mission-driven environment focused on restoring health and improving the quality of life for patients. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse backgrounds and perspectives.