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Job

Regulatory Affairs Coordinator 2

  • Job ref:

    9615

  • Location:

    Marlborough, United States

  • Sector:

    Quality Engineers

  • Contact:

    Kevin Sledge

  • Published:

    about 2 months ago

  • Consultant:

    Kevin Sledge

Regulatory Affairs Coordinator 2 

 

Essential Duties and Responsibilities:
• Demonstrated ability to coordinate complex projects.
• Strong oral and written communication and presentation skills
• Solid working knowledge of the US Regulations and European medical device directives
• Good analytical and problem solving skills.
• Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices.
• Experience with International submissions and MDR / 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

Qualifications

Education & Experience
• Bachelor's Degree required in the life sciences or engineering with a minimum of 3 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred). International RA experience preferred or
• Master’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry
• Understanding of FDA and European Medical device regulations. Working knowledge of the medical device product lifecycle. Product design and manufacturing change assessments for regulatory reporting. International regulations and submissions.

Skills
• Strong working knowledge of medical device regulations (21CFR) and FDA law
• Strong working knowledge of the regulatory requirements related to European medical device directives; additional experience with international registration requirements highly desirable
• Capacity to communicate regulations to technical functions within the company
• Ability to work with Regulatory Affairs Management to manage relationships with European Notified bodies
• Experience with document control systems such as Agile and Oracle
• Medical device software submission and validation experience desirable
• Strong writing skills with ability to write detailed information for submissions
• Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
• Strong verbal skills including presentation skills
• Strong interpersonal skills including the ability to interact with all levels of the company
• Strong computer skills including Microsoft Office