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Regulatory Affairs Associate

Danvers , MA

Posted: 07/25/2022 Industry: Z N/A Tech Writers & Documentation Job Number: 14657

Job Description

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 Associate

Hiring Organization: Connexion Systems & Engineering

  • Duration: Perm           
  • Pay rate: $ 80-85k
  • Job Location: Danvers, MA
  • Job# 14657



Regulatory Affairs Associate

Overview: Support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits, and regulatory submissions.


  • Assists, coordinates, or prepares US and international regulatory submissions.
  • Prepares or coordinates responses as requested by regulatory agencies or agents.
  • Prepares or maintains MDD technical files and related documentation.
  • Reviews clinical protocols to ensure appropriate collection of data to fulfill regulatory requirements.
  • Ensures all quality operating procedures (QOP), work instructions (WI), or policies are in compliance with EN ISO 13485:2016.
  • Reviews product promotional materials, labeling, records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintains knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Participates in internal audits, external supplier audits, and MDSAP surveillance audits.
  • Other duties as assigned



  • Bachelor's degree in life sciences or engineering.
  • Minimum of 1-year experience in IVF, embryology, biotechnology, or pharmaceutical industry.
  • Knowledge of electromechanical equipment and programmable systems preferred
  • Strong verbal and written communication skills.
  • Detail-orientated with demonstrated problem-solving skills and ability to multi-task.
  • Proficient in Microsoft Office suite (Word, Excel, Outlook).


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