Regulatory Affairs Director

Fidia Pharma • New Jersey, NJ

2d

About The Position

The Regulatory Affairs Director oversees regulatory affairs, quality assurance, pharmacovigilance quality assurance, and corporate compliance for Fidia’s US and Canadian operations. The role requires working knowledge of FDA regulations for Class II and Class III medical devices and HCP/T products, as well as Canadian medical-device regulations. The Director is responsible for new product registrations in the US and Canada, supporting company projects with internal and external stakeholders, maintaining the quality system under 21 CFR 820 and ISO 13485, and overseeing complaint handling, Medical Device Reporting, and recalls under applicable regulations. The position also has corporate compliance responsibilities, including compliance with US fraud and abuse laws and support for state licenses and permits needed to sell Fidia products in the US.

The Director serves as the Quality System Representative and Compliance Officer, manages regulatory personnel, and acts as a liaison among company executives, consultants, the FDA, and Fidia’s international regulatory personnel. The role develops regulatory strategies and leads US and Canadian submissions, while supporting audits, quality-system maintenance, training, and review of promotional materials and product labeling.

Fidia offers training and coaching programs, professional development opportunities, a pension fund with company integration, a health fund, merit review and referral programs, a company canteen, staff discounts, and access to a flu vaccination campaign. Fidia states that it promotes parity and inclusion and equal opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, or age.

Requirements

• Bachelor of Science degree in a science- or health-based discipline.
• At least 10 years of applicable experience in compliance, regulatory affairs, and quality systems.
• Working knowledge of FDA regulations for Class II and Class III medical devices and HCP/T products, and Canadian medical-device regulations.
• Regulatory Affairs certification is required.
• Ability to work independently and manage multiple tasks effectively.
• Technical-writing skills and proficiency compiling data for reports, policies, procedures, work instructions, and other technical documentation.
• Ability to travel as needed.
• Attend training on Fidia’s Quality Manual, applicable policies, procedures, and work instructions, as well as new-hire compliance and product training.

Responsibilities

• Oversee Quality Assurance and the PV QA Associate in customer product complaint handling, adverse events, and medical inquiries; work with the Medical Director and Quality Assurance on audits, root-cause analysis, and corrective and preventive actions; and manage regulatory personnel.
• Serve as Quality System Representative for compliance with 21 CFR 820 and conduct management reviews.
• Serve as Compliance Officer and ensure the compliance program is consistent with industry standards, such as AdvaMed.
• Renew FDA and Canadian annual registrations for Fidia USA and Fidia Farmaceutici; maintain medical-device listings and renewals; and submit annual compliance reports to state governments.
• Write and implement company policies, procedures, and work instructions; assist with internal and external audits; and maintain vendor Quality Agreements.
• Develop regulatory strategies for novel products to obtain regulatory approval.
• Lead US and Canadian regulatory submissions for Fidia Farmaceutici, including PMAs and supplements, annual reports, 510(k)s, 513(g)s, pre-submissions, and letters to file.
• Act as company liaison with the executive team, consultants, FDA, and international regulatory personnel at Fidia headquarters.
• Review promotional and training materials and product labeling for compliance with FDA regulations.
• Train new hires on Fidia’s compliance and regulatory policies and procedures.
• Take on additional responsibilities as assigned.
• Support obtaining state licenses and permits required to sell Fidia products in the US.

Benefits

• Unlimited access to training and coaching programs aligned with market best practices.
• Professional development opportunities through participation in internal job posting processes.
• Pension fund with company integration.
• Health fund.
• Merit review programs.
• Referral programs.
• Company canteen.
• Staff discounts.
• Access to a flu vaccination campaign.

What This Job Offers

• Job Type: Full-time
• Career Level: Director