Regulatory Affairs Specialist

10 hours ago


Marlborough, Massachusetts, United States JobRialto Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at JobRialto. The successful candidate will work closely with our regulatory, engineering, marketing, quality, and other professionals to ensure compliance with regulatory requirements and develop documentation and processes.

Key Responsibilities
  • Support continuous improvement activities, including regulatory procedure development and documentation, to align and standardize approach across products and teams.
  • Support regulatory compliance and develop, maintain, and improve documentation and processes.
  • Work closely with regulatory, engineering, marketing, quality, and other professionals to support customer inquiries and develop product compliance documentation.
  • Collaborate with regulatory colleagues to ensure a consistent and compliant approach is adopted within areas of responsibility.
  • Collect and summarize performance metrics to identify program weaknesses and recommend improvements in procedures or oversight.
Requirements
  • Bachelor's Degree (or international equivalent) in a related field such as Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Pharmaceutical Science, Pharmacy, or minimum of 8 years progressive regulatory affairs experience in medical device or pharmaceutical industry.
  • 5 years of relevant work experience.
  • Strong analytical skills.
  • Ability to work in a team environment with minimal supervision on projects and activities.
  • Ability to prioritize, plan, and evaluate deliverables.
  • Knowledge and experience conducting scientific, regulatory, or business research.
  • Excellent verbal and written communication skills with the ability to communicate in English in an easy-to-understand manner.


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