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Sr. Project Manager-Regulatory Affairs

System One
Montvale, NJ
  • Posted: over a month ago
  • Full-Time
Job Description

Title: Sr. Project Manager- Regulatory Affairs
Location: Montvale NJ
Start date: ASAP
Duration: Perm
Schedule: Monday thru Friday 8-4:30 (3 days on site 2 days remote)



Requirements:

- BS degree in Science, Engineering or equivalent, Masters degree preferred
- Minimum of 4 year’s regulatory affairs experience in the Med Device field is a must!
- In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA), and working with cross-functional project teams.
- History of successful device submissions
- Proficient with GLP/GCP requirements
- Experienced with regulatory requirements and standards governing global manufacturing and distribution of FDA regulated products

Responsibilities:
- Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
- Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).
- Guides and coaches other Regulatory Affairs Associates
- Assist in the preparation of special and periodic reports for FDA, such as those required to initiate regulated studies (522 Order)
- Provide support for currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval.
- Submission and Compliance Project Management - Develops, implements and manages systems to track required reports, supplemental submissions and post marketing commitments.
- Process Owner for client Project Management Process, maintaining SOP/Work Instructions/Forms and providing training
- Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.
- Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, IDN’s, etc.) and develops solutions to address anticipated obstacles.
-Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches and advises internal stakeholders on a course of action to expedite development for products


System One

Address

Montvale, NJ
USA

Industry

Government

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