Randstad Regulatory Affairs Associate in Westford, Massachusetts

Regulatory Affairs Associate

job details:

  • location:Westford, MA

  • salary:$30 - $45 per hour

  • date posted:Friday, December 7, 2018

  • experience:Experienced

  • job type:Temporary

  • industry:Professional, Scientific, and Technical Services

  • reference:S_711950

  • questions:jacqueline.otis@randstadusa.com858-410-8000

job description

Regulatory Affairs Associate

Randstad is seeking a Regulatory Affairs Specialist for a long term project at one of its biotechnology clients in Westford, MA. This client is a leading developer, manufacturer, and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood, and aid in biomedical research. You will work in an atmosphere that is stimulating, innovative, and customer focused.

Responsibilities:

This person will be responsible for international regulatory activities associated with Notified Body in EU, and other international regulatory agencies. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.

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 and Medical Device Regulations (MDR)

  • Good analytical and problem solving skills.

  • Creation and maintenance of technical documentation relating to MDD / MDR

  • 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 MDD / 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

Working hours: 8:00 AM - 5:00 PM

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 systemsPLM and ERP 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

Education:

Bachelors

Experience:

Experienced

Qualifications:

  • Bachelor's Degree required in the life sciences or engineering with a minimum of 3 years direct experience in Regulatory Affairs (within an MDD / 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 MDD / MDR / IVD Industry

  • Understanding of FDA and European Medical Ddevice Directives and Regulations.

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

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