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10556
Contract

Regulatory Affairs Coordinator

Location: Marlborough ,

Connexion strives to be the unrivaled staffing solution for both job seekers and hiring organizations by expertly connecting talent with opportunity. We build world class teams for our customers, and better the lives of our candidates by providing them with fulfilling careers.

 

Connexion would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:

 

Regulatory Affairs Coordinator

Description:

We are 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.

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

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

 

Date Posted: 10/9/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Regulatory Affairs Coordinator   

Industry: IT/Manufacturing

Location: Marlboro, MA

Employment Type: Full Time, Contract

Pay Range:  40-50/hr.  

Duration: 8 months +

Job #: bh10556

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776