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Regulatory Affairs Specialist

Location : East Hanover NJ US 07936
Job Type : Temp/Contract
Reference Code : 19934-BZ1
Compensation : open - 55-65/h
Start Date : 08/26/2019
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract position for a Regulatory Affairs Specialist responsible for interpreting regulatory requirements and determining strategy to obtain registrations for US (Class I & II) and EU (Class I, IIa, IIb, III) and International registrations of orthopedic devices for hip and knee implants.

  • Responsible to coordinate/develop FDA Submissions (510(k)).

  • Participates in a cross-functional product development team responsible for new product development from concept through product launch.

  • Review changes to existing products and SOPs to define the requirements for regulatory submissions worldwide.

  • Assists in generating/reviewing design assurance documentation for the project Design History File (DHF).

  • Assists/coordinates International Product Registrations with external consultants.

  • Actively participate in evaluation of regulatory compliance of document/product/process/test methods changes.

  • Review labeling and labels for compliance with regulatory requirements.

  • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and law.

  • Represent Company to US Regulatory agencies and interact with FDA, EU, etc. personnel to expedite pending applications, resolve Regulatory matters and manage development meetings for Regulatory Submissions.

Required Qualifications :

  • BS Engineering or Science

  • Knowledge with anatomy as it pertains to artificial orthopedic joints including knee and hip.

  • Minimum 2 years Regulatory Affairs experience with at least 2 years in Orthopedics.

  • Knowledge of US and international medical device regulatory requirements.

  • Experienced in writing and submitting 510(k) premarket notifications to U.S FDA

  • Must be familiar with US, EU, and International Regulations, FDA guidance for Medical Devices, specifically Orthopedics.

  • Experience with reviewing and contributing to project related design control documents (i.e. project schedules, FMEAs, V&V reports, etc.) as required by various regulatory / certification bodies (i.e. FDA, BSi, NMPA, etc.).

  • Must have demonstrated experience and comfort in regulatory related audits.

Contact: Bill Zukowsky

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