Job Listing Description

Regulatory Affairs Specialist


Duties & Responsibilities:

  • Prepare, compile and publish electronic pre-market and post-market regulatory submissions
  • Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark Interact with business partners to support WW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.).
  • Develop and execute submission strategies for assigned projects.
  • Monitor progress on key project deliverables and provide status updates on regular basis.
  • Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance Develop and/or revise regulatory procedures

Preferred Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:

  • Demonstrated ability to coordinate complex projects.
  • Strong oral and written communication and presentation skills
  • Solid working knowledge of the US Regulations and European IVD and medical device directives
  • Good analytical and problem-solving skills.
  • Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
  • Experience with International submissions and IVDs highly desirable Capacity to communicate regulations to technical functions within the company
  • Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
  • Solid computer skills in Microsoft Office

Education & Experience:

  • Bachelor’s degree required in the life sciences or engineering with a minimum of 2 – 4 years direct experience in Regulatory Affairs (within an IVD industry preferred).
  • International RA experience preferred or a minimum of 1-year direct experience in Regulatory Affairs within the IVD Industry

Preferred Specialized Knowledge:

  • Understanding of FDA and European Medical device and IVD regulations.
  • Working knowledge of the medical device product lifecycle.
  • Product design and manufacturing change assessments for regulatory reporting.
  • International regulations and submissions

Job Number: 2010116532
Job Location:
Duration: 5 months
Input Date: 09/09/2020
Attention: Jack Beabout
Address: 2154 N CENTER ST STE 405D
City, State: NORTH CHARLESTON, SC 29406
800 Phone: 866/224-2745

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