Director Regulatory Affairs
Company: Sterling Engineering, Inc.
Posted on: September 13, 2023
Title: Director of Regulatory Affairs
Location: Schaumburg, IL
Hire Type: Direct Hire
Overview:Sterling has helped build careers for thousands for
professionals like yourself. Our expert recruiters support you at
every step in the process and as a Best of Staffing company,
Sterling provides exciting work with exceptional employers across
Job Summary:Develop, lead, and execute the companys regulatory
compliance strategy - including Drugs and Medical devices. Ensure
complete compliance with all FDA, QSR, cGMP, and other federal and
state regulations, and with corresponding international regulations
in all markets served. The scope of this position impacts all
products in all phases of manufacturing and service.
- Provide leadership for the Regulatory Affairs function at all
- Ensure compliance with international GMPs, US FDA regulations,
etc. in all countries of manufacture and exportation.
- Serve as the Official Contact with FDA and related regulatory
authorities at the federal, state local and international
- Work with executive management and aid in determination of
extraordinary matters (recalls, market withdrawals, regulatory
matters, compliance issues, etc.).
- Ensure timely regulatory filings for the company (device
listings, establishment registrations, adverse event reporting,
etc.). Responsible for establishment and maintenance of filing
procedures, tracking, re-certification, etc.
- Serve as consultant and advisor for new products, facilitating
the timely introduction of safe and effective new products while
ensuring that all customer and regulatory requirements are
researched and communicated to the design team, are subsequently
met prior to launch, and are monitored for compliance in the
production and post-market phases,
- Ensure international market growth by providing the technical,
quality and regulatory documents that are required to register
products in each country.
- Continually monitor the effectiveness of the production and
business processes that impact customer satisfaction (innovation,
marketing communication, order fulfillment, purchasing and
manufacturing), to develop, lead and execute corporate strategy
aimed at maximizing the results of those processes, and to report
progress to the corporate Officers globally.
- Thoroughly research all guidance (ICH, FDA, QSR, etc.) related
to regulatory matters, and report on same to the appropriate
- Additional duties as required.
- Bachelors Degree in Science or Engineering is required. Masters
Degree is preferred.
- 10+ years in a significant corporate regulatory within an
FDA-regulated drugs and devices industry, with 8 years of
- Comprehensive knowledge of FDA, cGMP is required.
- Well versed with 21 CFR 803 (Medical Device Regulations).
- Experience with international GMP/RA compliance requirements,
especially EMEA, Latin America and Canada is preferred.
- Proven record for exceeding quality and business goals.
- Thorough understanding and working knowledge of 510(k) & PMA
submissions, and ANDAs.
Qualified applicants will receive consideration for employment
without regard to race, color, age, religion, sex, sexual
orientation, gender identity, national origin, disability,
protected veteran status, or genetic information.
Keywords: Sterling Engineering, Inc., Schaumburg , Director Regulatory Affairs, Executive , Schaumburg, Illinois
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