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Compliance & Regulatory Affairs Manager

Company: Bartech Group
Location: Houston
Posted on: May 5, 2021

Job Description:

Job Description If you are an experienced Compliance & Regulatory Affairs Manager looking for a position with a leading company, Bartech can help! We are a leading staffing firm and our clients include some over the nation's biggest companies. Our client has a need for a Compliance & Regulatory Affairs Manager. This is a contract position; however it is not uncommon for assignments to transition into permanent positions with our client companies. If you have the background we are looking for, and you are interested in an opportunity to get your foot in the door with leading company, we want to talk with you! Applicant must be eligible to work in the US for immediate opening. For this opportunity, the successful candidate will be directly employed by Bartech Staffing as a W2 employee while providing services to our end client. Compliance & Regulatory Affairs Manager Job Responsibilities Your specific duties as a Compliance & Regulatory Affairs Manager will include:

  • Compensation (Range): Up to $150K + 10% annual bonus
  • The Compliance and Regulatory Affairs Manager will lead regulatory efforts to prepare the company to manufacture and/or distribute pharmaceutical products and medical devices.
  • The position will interact locally with pharmaceutical manufacturing efforts and with contract manufacturing of a class II medical device.
  • Additionally, this position will assist the quality systems leadership to prepare or modify SOP's in order to achieve FDA compliance for expected new products. The position will work with quality systems teams for the resolution of customer complaints and adverse events including FDA reporting, as required. The position will be located in Plumsteadville, PA or Houston, TX.
  • Organize and submit Medical device and drug approval filings with the US Food and Drug Administration (FDA) to obtain approval in a timely fashion.
  • Organize and submit product and process changes to the US FDA to obtain approval in a timely fashion.
  • Create, execute, and review product qualification and process validation protocols required to support FDA submissions.
  • Lead company efforts for FDA Track and Trace regulations including leading efforts for system selection and SOP generation.
  • Submit adverse event reports for all products, both drug and medical device as required.
  • Provide regulatory inputs in the investigation of customer complaints. Compliance & Regulatory Affairs Manager Job Requirements As a Compliance & Regulatory Affairs Manager you must represent our company well by being responsible, punctual and motivated to go above and beyond the call of duty. You must also be highly detail-oriented and organized with excellent analytic and problem-solving abilities. It is also important that you display excellent verbal and written communication and interpersonal skills.
    • Bachelor's degree in Mechanical, Biomedical, or Electrical Engineering or equivalent experience.
    • Minimum of three years of experience in US FDA regulatory affairs, ideally related to Class II or higher medical devices which contain software and with pharmaceutical products.
    • Complete knowledge of US FDA Medical Device regulations and ISO 13485
    • Demonstrated experience and ability to create submissions for FDA class II medical devices, with experience with class III a plus.
    • Knowledge of quality system requirements for pharmaceuticals and medical devices including design controls, supplier contracts, and maintaining contract manufacturers. This position will be responsible for creating documents to execute these activities working with local quality systems leadership.
    • High level of attention to detail and organization skills.
    • Effective verbal and written communication skills.
    • Knowledge of and experience in executing risk or hazard assessments for medical devices including but not limited to assessment of hardware and software changes.
    • Ability to lift 50 lbs. and stand for extended periods of tim
    • Ability to travel as required up to 20% including international travel as required Compliance & Regulatory Affairs Manager Benefits As a Compliance & Regulatory Affairs Manager with Bartech, you will be working through an established and respected staffing organization with over 40 years of serving as a trusted partner to our client companies. We are dedicated to providing our talent with personal, responsive attention, and will assign an employee care representative to answer any questions or concerns that you might have. Depending upon the client, the assignment and your performance, you can find potential opportunities for direct employment. Your hard work and professional dedication will be rewarded with competitive compensation, including benefits. Available benefits for Compliance & Regulatory Affairs Manager Position may include (but are not limited to):
      • Exceptional medical, dental, and vision
      • 401(k) Make the most of your experience! Apply now!

Keywords: Bartech Group, Houston , Compliance & Regulatory Affairs Manager, Executive , Houston, Texas

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