Regulatory Affairs Specialist Job at Incubation Systems Private Limited

Incubation Systems Private Limited Danvers, MA

We are hiring for our client, a US based Medical Device manufacturer.

Duration: 10 months Contract

Location: Danvers, MA

Shift Hours: 8:00am to 5:00pm

Description:

  • Completes a variety of administrative tasks for Regulatory project support which may include but is not limited to document formatting, document generation, document storage co-ordination and shipping of regulatory submissions.
  • Manage multiple deliverables including project planning and creation of action plans, tracking of bowlers, escalation communication, stakeholder management and Daily Management.
  • Works cross-functionally on specific projects as they arise (for example with R&D and/or QA).

Required Skills/Experience:

  • 1-3 years of RA experience required.
  • High School Diploma or equivalent required.
  • Associate or bachelor’s Degree preferred in science or related.
  • IVD Regulatory Affairs or Quality Assurance experience is very beneficial and highly desirable.

Competencies:

  • Excellent MS Word and MS Excel skills.
  • Strong, independent worker capable of operating in a fast-paced, constantly changing environment.
  • A self-starter able to manage their own workload and prioritize tasks accordingly.
  • Must be results oriented with excellent organizational and time management skills.
  • Excellent attention to detail.
  • Must possess strong interpersonal and communication skills.

Job Types: Full-time, Contract

Salary: $40.00 - $41.00 per hour

Schedule:

  • 8 hour shift
  • Day shift

Work Location: One location




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