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 compliance in healthcare. Your experience has equipped you with the ability to navigate regulatory frameworks and ensure that products meet necessary standards. You are detail-oriented and possess excellent communication skills, allowing you to effectively collaborate with cross-functional teams. You are passionate about improving patient outcomes and have a track record of successfully managing regulatory submissions and approvals. You thrive in environments that require strategic thinking and problem-solving, and you are committed to continuous professional development.

Desirable

Experience with clinical trials and an understanding of FDA regulations would be advantageous. Familiarity with quality management systems and risk management processes is also a plus. You may have worked in a similar role within a medical device or pharmaceutical company, which has given you insights into the regulatory landscape.

What you'll do

In this role, you will be responsible for overseeing regulatory submissions and ensuring compliance with applicable regulations. You will work closely with engineering, clinical research, and business development teams to define market requirements and specifications. Your role will involve preparing and submitting regulatory documents to the FDA and other regulatory bodies, as well as maintaining up-to-date knowledge of regulatory changes that may impact the company. You will also be tasked with developing and implementing regulatory strategies that align with the company's mission to improve patient care. Additionally, you will provide training and guidance to internal teams on regulatory requirements and best practices.

What we offer

Axogen offers a comprehensive benefits package that includes educational assistance, a matching 401(k) retirement plan, and an employee stock purchase plan. You will be part of a friendly and open team culture that values unique perspectives and fosters professional growth. The company is committed to making a profound impact on patients' lives, and you will have the opportunity to contribute to this mission from day one. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse backgrounds and perspectives.