Quality / Regulatory Specialist

Natrona Heights, PA

Job ID: Req-3514 Industry: Professional Services Pay Rate: Negotiable

A medical device company, located northeast of Pittsburgh, is seeking a Quality / Regulatory Specialist.


  • Responsible for maintaining a GMP compliant Quality Management System for a Medical Device manufacturer's implemented systems, processes, equipment and materials compliance to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, CE MDD 93/42/EEC, and ISO 13485 regulatory Standards.
  • Track, document, and report any changes in, or improvements to, the Quality System.
  • Inspect Production quality processes, products, and personnel in all production areas regularly to ensure compliance.
  • Investigate and document any problems relating to the product, process, or Quality System.
  • Initiate, recommend, and provide solutions to quality system problems.
  • Document and verify the implementation or correction of solutions to processes, products, and equipment.
  • Schedule and conduct internal and external audits.
  • Assist in sourcing vendors by vendor qualification.
  • Qualify Operations personnel on Quality Processes and related information.
  • Inform and influence workers on improvements and corrections.
  • Assist in compiling Device Master Records (DMR) and Design History Files (DHF).
  • Prepare for and conduct audits from the Food and Drug Administration (FDA), CE, and customers.
  • Some travel may be required either domestically or internationally.


  • Bachelor’s Degree in a related field and a minimum of 2 years of quality and regulatory experience within a medical manufacturing environment
  • Must have experience with FDA, cGMP, CE, and ISO regulatory standards
  • Proficient with MS Office
  • Excellent verbal and written skills
  • Ability to work in a fast paced environment with the ability to manage multiple, simultaneous responsibilities



Hours: Monday-Friday, 8:00am-5:00pm

JH Technical Services

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