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Regulatory Affairs Coordinator

Location : Danvers, MA
Hours : Full Time
Required Years of Experience : 1-3 years
Required Education : High School Diploma or equivalent
Travel : No
Relocation : No

Job Description :
Our client is part of a team of life science companies who are developing products that are paving the way in the fight to save lives.


If you are looking for an opportunity to contribute your skills and knowledge and be part of a team, they have an opportunity for a Regulatory Affairs Coordinator


In this role you will:

  • Complete a variety of administrative tasks for Regulatory project support -document formatting, document generation, document storage co-ordination and shipping of regulatory submissions

  • Manage multiple deliverables - project planning and creation of action plans, tracking of bowlers, escalation communication, stakeholder management and Daily Management.

  • Coordinate with other teams on specific projects as needed.


Salary:  $DOE/ hr (contract)

Schedule: FT, 40 hrs, Mon-Fri, 8:00am - 5:00pm (2 days Hybrid and 3 days on-site)

Location: Danvers, MA

Benefits:  Health Insurance available – Medical / Dental/ Vision



Required Qualifications :

  • High School Diploma or equivalent -Required!

  • Associate or bachelor’s Degree - science or related – Preferred!

  • 1-3 years of Regulatory Affairs experience -Required!

  • Previous experience in IVD Regulatory Affairs or Quality Assurance – Required!

  • Excellent MS Word and MS Excel skills

  • Ability to work independently and capable of operating in a fast-paced, constantly changing environment

  • Collaborative Team Player

  • Skills to be successful - self-starter, ability to manage workload and prioritize tasks accordingly, results oriented, excellent organizational and time management skills, attention to detail. strong interpersonal and communication skills

  • Ability to Travel 10% as needed


Keywords:  regulatory affairs, IVD, quality, regulatory quality assurance, manufacturing, FDA, ISO, GMP, quality systems, life science, engineering, medical device, QA, IVD, quality systems


"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".


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