Job description

Fidia Pharma USA Inc. is a wholly-owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid (HA) market segment. Fidia Pharma USA is focused on continually expanding Fidia’s position in the U.S. by growing the company business and image of global leader in HA research, while upholding the company's mission to provide consumers with innovative products that offer quality, safety and performance. Drawing on the strengths of the parent company, the Fidia Pharma USA current product portfolio focuses primarily on therapeutic areas such as joint healthcare, women’s health and Orthobiologics.

Job Description:

The Senior Regulatory Affairs Specialist must have a working knowledge of FDA regulations for Class III and Class II medical devices and HCP/T products. In this position, you will assist with new product registrations in the US and Canada, collaborate with internal and external stakeholders to support of company projects, and assist with maintaining the quality system per 21 CFR 820 and ISO 13485. You will also assist with post market activities as required by 21 CFR Parts 820, 803 and 806 for complaint handling, Medical Device Reporting, and Recalls.

Responsibilities:

The Senior Regulatory Affairs Specialist has the following responsibilities and duties:

• Regulatory support through the product life cycle as a member on project teams including but not limited to developing regulatory strategies, timeline development, and reviewing technical documents
• Interface and coordinate with corporate headquarters in Italy on regulatory projects
• Prepare and support 510(k), IDE, PMA and Canadian submissions as required
• Provide support for post market activities including reviewing advertising, and promotional materials, preparing Letters to File and Annual Reports, create change control documents for labeling changes and renewing Canadian and US establishment registrations and device listings
• Assist with the maintenance of the quality system per 21 CFR 820 by writing policies, procedures, and work instructions, assisting with internal and external auditing, and maintenance of vendor Quality Agreements
• Act as backup for complaint handling and adverse event reporting
• Take on additional responsibilities as assigned

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

The Senior Regulatory Affairs Specialist should have the following skills, education and experience:

• BS in a science or health-based discipline with 5 years experience in the areas of product registration, compliance, and quality systems
• Regulatory Affairs Certification (RAC) desired
• Experience with filing 510(k)s, PMAs, IDEs or Canadian submissions for registering medical devices
• Must be able to work independently to complete assigned tasks with strong multi-tasking abilities
• Working knowledge of Human Cells, Tissues, and Cellular, and Tissue-based Products (HCT/Ps) regulations
• Must have technical writing skills and be proficient at compiling successful submissions, policies, procedures, work instructions and other technical documentation
• Must be able to travel as needed

Training Requirements:

The Senior Regulatory Affairs Specialist needs to be trained on the following to be able to fulfill job requirements:

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

Fidia Pharma USA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: Hybrid remote in Florham Park, NJ 07932

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