Sr. Regulatory Compliance Specialist

Actalent
Published
March 31, 2023
Location
Richmond, IL
Category
Job Type
Work Setting
In-office

Description

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Job Description

  • The Senior Regulatory Affairs Specialist is expected to provide collaborative leadership within the Quality Assurance & Regulatory Compliance team as well as within the organization and global LBS teams as required.
  • The Specialist will work with cross functional teams to bring IVD (In-Vitro Diagnostic), medical and chemical products to market and ensure ongoing compliance while continuing to develop regulatory affairs skills.
  • This role will lead major regulatory efforts requiring cross-site partnership and execution.
  • The Senior Regulatory Compliance Specialist will conduct improvements to standard work for product registrations, listings, and renewals globally. Strong problem solving and decision-making skills are expected to drive regulatory compliance efforts.
  • The Senior Regulatory Compliance Specialist will drive the Danaher Business Systems (DBS) mindset to improve quality, processes, and innovation by applying tools and continuous improvement mind-set.
  • Provide product regulatory strategy and registration guidance on New Product Development, Design Change and Sustaining projects.
  • Identify pathways to market and requirements to sustain regulatory compliance for chemical products, IVD products and instrumentation.
  • Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files/Device Files and DoCs, to regulatory agencies or to commercial partners, advise on the submission strategy.
  • Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
  • Review and approve Marketing, Advertising, Promotional and Scientific Materials to ensure compliance with regulations in country/countries where materials are distributed.
  • Provide subject matter expertise during internal and external site audits (i.e. MDSAP, GMP, etc.)
  • Budget planning.

Skills

  • Regulatory Affairs, IVD, Regulatory Strategy, Global Registration, Regulatory Submissions, FDA, GMP, ISO 13485:2016, Health Canada, Histology, Pathology, Medical Device.
  • Regulatory Affairs,IVD,Regulatory Strategy,Global Registration.

Skills & Qualifications

Required

  • Education: Bachelor's Degree, preferably in Engineering or Life Sciences.
  • 8+ years-experience within medical device/IVD; Histology/Pathology experience is a plus.
  • FDA (Class I & II) and Health Canada regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
  • Knowledge of chemical compliance regulations (i.e.: RoHS, TSCA, REACH etc.).
  • Experience with ISO 13485:2016, IVD Regulations, FDA GMP, and domestic/international Medical Device Regulations.
  • Experience with support of cross functional new product development from a RA perspective including risk management, review of technical files, product labels/IFU, new product approval and registration.
  • Experience with Global Registrations and Change Control Desired Experience/Skills:  RAC (Regulatory Affairs Certification) is a plus.
  • Ability to identify, analyze and mitigate risk.
  • Strong organizational skills.
  • Strong communication skills and ability to explain difficult or sensitive information, works to build consensus.
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