Regulatory Affairs Director

Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Eye Care, Skin Care, Specialty Care, Health&Wellness Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.

Job Description

The Regulatory Affairs Director (RA) must have a working knowledge of FDA regulations for Class III and Class II medical devices and HCP/T products and Canadian regulations for medical devices. This position is responsible for new product registrations in the US and Canada, collaborating with internal and external stakeholders to support of company projects, maintaining the quality system per 21 CFR 820 and ISO 13485 and overseeing the activities as required by 21 CFR Parts 820, 803 and 806 for complaint handling, Medical Device Reporting, and Recalls. The position also includes corporate compliance responsibilities to ensure compliance to US fraud and abuse laws as well as assisting with obtaining state licenses and permits to sell Fidia products in the US.

Responsibilities:

The Director, Regulatory Affairs has the following responsibilities and duties:

• Responsible for overseeing Quality Assurance and PV QA Associate for customer product complaint handling, adverse events (AE) or medical inquiries and work with the Medical Director and Quality Assurance on any audit, root cause and corrective/preventive actions that may be required and manage regulatory personnel.
• Quality System Representative for compliance to 21 CFR 820 for Fidia’s quality system per 21 CFR 820 and conduct management reviews.
• Compliance Officer to ensure compliance program is consistent with industry standards (e.g. AdvaMED)
• Responsible for renewing FDA and Canadian annual registrations for Fidia USA and Fidia Farmaceutici, maintaining medical device listings as well as renewals and annual compliance reports for various state governments
• Write and implement company policies, procedures, and work instructions, assist with internal and external auditing, and maintenance of vendor Quality Agreements
• Developed regulatory strategies for novel products to obtain regulatory approval
• US regulatory lead for US and Canadian submissions for Fidia Farmaceutici including PMAs & supplements, annual reports, 510(k)s, 513(g)s, pre-submissions and letters to file
• Company liaison with executive team, consultants, FDA, and international regulatory personnel at Fidia headquarters
• Review promotional & training material and product labeling for compliance to FDA regulations
• Conduct training for new hires on Fidia’s compliance and regulatory policies and procedures
• Take on additional responsibilities as assigned

Required Education/Knowledge, Work Experience, Skills, and Abilities:

• BS in a science or health-based discipline with applicable 10 years’ experience in the areas of compliance, regulatory affairs and quality systems
• Must be able to work independently to complete assigned tasks with strong multi-tasking abilities
• Must have technical writing skills and be proficient at compiling data for reports, policies, procedures, work instructions and other technical documentation
• Must be able to travel as needed

Training Requirements:

• Fidia’s Quality Manual, Policies, Procedures and Work Instructions applicable to the job function
• Should attend new hire training for compliance and products
• Regulatory Affair Certification is required

Fidia benefits:
In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.

Fidia Farmaceutici promotes parity and inclusion in all its actions.
All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age.
All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.