Program Manager, Regulatory Affairs

Organogenesis Inc.; Canton (MA); In loco; USD 119.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

401k plan

Medical, dental, vision

Health savings / flexible spending

Paid leave

Education assistance

Descrizione del lavoro

Organogenesis seeks an experienced regulatory affairs professional to manage regulatory requirements for medical devices and biologics, including HCT/Ps. You will develop regulatory strategies and submissions for FDA and international bodies, and guide product changes for US marketed products.

Role requires collaboration with development, manufacturing and quality teams, evaluation of changes for filing requirements, and strong knowledge of FDA, EU, and ICH regulations.

Competenze

• BS degree in science, technology, engineering, or mathematics.
• Advanced degree and/or regulatory credentials (MS, RAC) preferred.
• 5+ years regulatory affairs experience in biotech.
• 3+ years developing regulatory strategies and preparing submissions.
• Experience with regulatory product lifecycle management.

Mansioni

• Develop regulatory strategies and submissions for FDA and international regulators.
• Collaborate with process development, manufacturing and quality teams for submissions.
• Review protocols, reports, and labeling changes for regulatory impact.
• Ensure compliance with QSR, cGMP, and ICH/EU requirements.
• Lead regulatory strategy meetings and present requirements.

Conoscenze

Regulatory strategy

Regulatory submissions

Regulatory standards

Documentation

Communication

Formazione

BS in science/engineering/math

MS or RAC preferred

Strumenti

Regulatory lifecycle management

PMA/IND/BLA/510(k) filings

Descrizione del lavoro

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 byEmpowering 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 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

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.

The anticipated annualized base salary is $119,000 - $140,000and 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.

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.