What are the responsibilities and job description for the Regulatory Affairs Specialist II position at Organogenesis?
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.
What You Will Achieve:
In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic and products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for product changes to US marketed products.
How You Will Achieve It:
- Working closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation.
- Providing input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies.
- Ensuring regulatory compliance with QSR and cGMP requirements and stay apprised of ICH, FDA and EU requirements.
- Evaluating changes to determine the filing requirements and impact on AATB certifications, state licenses, and FDA registrations.
- Review of labeling changes, and advertising and promotional material.
- Review of complaints for medical device reporting (MDR) requirements.
