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12637
PERM

Regulatory Affairs Specialist

Location: Lawrence, Massachusetts

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Regulatory Affairs Specialist

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Permanent
  • Pay rate:  $70-80K
  • Job Location:  Andover, MA
  • Job#: bh12637
     

 

Regulatory Affairs Specialist

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES INCLUDE:

• Prepare and maintain regulatory submissions and registration of complex Class III devices in the US and in international markets

• Maintain documentation and perform project management tasks, including record keeping and tracking due dates for FDA and international regulatory submissions.

• Assist with the preparation of FDA applications and other international regulatory documents, including EU Technical Files and documentation related to EU MDR certification

• Assist with vigilance reporting in the US and around the world

• Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations; participation in FDA and notified body audits as required

BACKGROUND AND QUALIFICATIONS:

• 2+ years regulatory experience in the medical device industry with a proven record of successful regulatory submissions (Class III experience preferred but not required)

• Ability to communicate ideas and information clearly, effectively and frequently (oral and written)

• Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results

• Ability to act independently to determine methods and procedures

• Must be detail oriented with strong organizational skills

• Must have strong interpersonal skills with willingness to be held accountable for deliverables

• Ability to utilize effective analytical and decision-making skills

• Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities

EDUCATION:

• Bachelor’s in Engineering, Life or Biological Sciences, or related field, MS a plus

 

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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