Regulatory Affairs Specialist

Piper Companies   •  

King Of Prussia, PA

Industry: Staffing

  •  

5 - 7 years

Posted 60 days ago

This job is no longer available.

JOB DESCRIPTION

Piper Companies is looking for a Regulatory Affairs Specialist to assist in writing and obtaining clearance for the 510(k) submissions to the FDA for class II & class II medical device products for a Device Manufacturer in King of Prussia, PA.

Responsibilities for the Regulatory Affairs Specialist include:

  • Work with R&D and management to prepare/review 510(k) submissions
  • Prepare final 510(k) submissions
  • Interact with FDA to submit 510(k) documents and responses in timely manner
  • Work with consulting surgeons, physicians to obtain and review clinical study data
  • Train new staff of new, relevant Regulatory processes as necessary
  • Assist in preparation of FDA reports
  • Ensure conformance to 21 CFR regulations, 1S013485,1S014971, & EU MDR.
  • Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems

Qualifications for the Regulatory Affairs Specialist include:

  • Bachelor's Degree in Heath or Science-related field, Engineering degree is a plus
  • Minimum 5 years experience in the Medical Device industry (Spinal devices preferred)
  • Minimum 2 years experience in Regulatory Affairs
  • Excellent verbal, written and organizational skills
  • Good computer skills
  • Must be detailed oriented

Compensation for the Regulatory Affairs Specialist include:

  • 6 month Contract-to-Hire
  • Hourly range: $38.46/hour - $48.08/hour ($80,000 - $100,000)


Salary

$80K - $100K