Compliance & Regulatory Affairs Manager
Company: Bartech Group
Posted on: May 5, 2021
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
- 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
- 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
- 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
- Demonstrated experience and ability to create submissions for
FDA class II medical devices, with experience with class III a
- 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
- 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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