Regulatory Affairs Specialist II
85 Dan Road, Canton, Massachusetts, 02021, United States
Job Req code 315
Category: Regulatory Affairs
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.
What you need to achieve:
- BS degree is required with a degree in science, technology, engineering, or mathematics preferred.
- 2 years or Regulatory experience in biotech, medical device or pharma
- Working knowledge of FDA and International Biologics/Drug/Device regulations is preferred.
- In addition, prior experience with medical devices 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.
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, and Sprint
We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.