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Regulatory Affairs-Technical Writer

Job Title: Regulatory Technical Writer-Medical Device
Location: Remote
Start Date: Immediate

Responsibilities:

  • Develops technical content, format and accountability for regulatory submissions and related supplements and amendments.
  • Advises project teams regarding the development and implementation of regulatory strategy through the analytic, GMP and clinical development processes.
  • Establishes and maintains excellent relationships with regulatory agency personnel.
  • Responds to requests for additional data, organizes and manages participation in meetings.
  • Negotiates directly with regulatory authorities regarding company's filings.
  • Reviews and approves technical data and verifies accuracy of clinical data and execution of preclinical and clinical projects to regulatory authorities.
  • Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
  • Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
  • Coordinates with other departments, corporate or marketing partners, and outsourcing partners to achieve project goals.
  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
  • Reviews all external materials for regulatory compliance.

Requirements:

  • Typically 10 years experience in the medical device industry.
  • 7+ years medical device regulatory affairs experience with regulatory processes including direct contact with regulatory agencies; full knowledge of FDA 510(k), EU CE Clearance & notified body regulations and guidelines, and the ability to provide interpretations of the information to others.
  • Strong knowledge of current US and EU regulations.
  • Experience with developing and implementing competitive regulatory strategies.
  • Solid understanding of dossier requirements for 510 (k), PMA, CTA, Design Master File, ISO 13485 and 21 CFR 820.
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio.
  • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
  • Must possess knowledge and experience with FDA and EMA electronic authoring, global standards from ICH, GHTF
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Company
System One
Posted
10/14/2021
Salary Range
$50,000.00 - 74,000.00
per Year
Salary range estimated by
Location
South Padre Island, TX 78597, US