Randstad Senior Regulatory Affairs Specialist in Marlborough, Massachusetts

Senior Regulatory Affairs Specialist

job details:

  • location:Marlborough, MA

  • salary:$40 - $45 per hour

  • date posted:Tuesday, November 27, 2018

  • experience:Experienced

  • job type:Temporary

  • industry:Professional, Scientific, and Technical Services

  • reference:S_708327

job description

Senior Regulatory Affairs Specialist

Seeking a Regulatory Affairs Specialist 2 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.

Responsibilities:

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

? 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

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

Skills:

Qualifications Education & Experience -

  • Bachelor's Degree required in the life sciences or engineering with a minimum of 3-5 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred).

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

Education:

Bachelors

Experience:

Experienced

Qualifications:

Skills

? Ability to work with Regulatory Affairs Management to manage relationships with European Notified bodies

? Experience with document control systems such as Agile and Oracle preferred

? 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

? Capacity to communicate regulations to technical functions within the company

? Working knowledge of medical device regulations (21CFR) and FDA law

? Working knowledge of the regulatory requirements related to European medical device directives preferred; additional experience with international registration requirements highly desirable

Please apply directly to the posting for consideration.

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