What You Will Achieve: In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic 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.
- Review of events related to potential biologic deviation reporting (BPDR).
Requirements What you need to achieve: - BS degree is required with a degree in science, technology, engineering, or mathematics. Advanced degree and/or regulatory credentials (i.e., MS, RAC) is preferred.
- A minimum of 5 years of relevant regulatory affairs experience in the biotech industry required; a minimum of 3 years of experience in developing regulatory strategies, planning and preparing regulatory submissions required.
- Experience with regulatory product lifecycle management required.
- Regulatory experience with development of Medical Device and Biologic products required, including working knowledge in the submission of regulatory filings for device and/or biologic products; experience with PMA, IND, BLA and/or 510(k).
- Must have a good working knowledge of relevant regulations and industry standards. Strong organizational, interpersonal and written/verbal communication skills required.
- Experience with technical aspects of product development and manufacturing.
Other Skills/Abilities: - Working knowledge of FDA and International Biologics/Drug/Device regulations is preferred.
- In addition, prior experience with medical device and biologic development and registrations is a plus.
- Ability to prioritize and multi-task projects independently is preferred.
- Strong organizational, interpersonal and written/verbal communication skills are required.
- Ability to lead meetings by preparing and presenting regulatory strategies and requirements is required.
What can we offer you? - 401k -- generous employer match with immediate vesting and financial planning resources
- Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
- Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
- Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
- Paid maternity leave and parental leave for all new parents
- Adoption benefits
- Education Assistance Policy - $5,000 per year for all employees
- Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
- Employee Assistance Program
- Generous paid time off including vacation, floating holidays, sick days, and company holidays
- Free parking including an electric charging station (Canton and La Jolla)
- Discounts at BJs Wholesale, Dell, Sullivan Tire
The anticipated annualized base salary is $119,000 - $140,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.
