Sterling Engineering, Inc. https://cdn.haleymarketing.com/templates/63335/logos/square_logo.png https://www.sterling-engineering.com https://www.sterling-engineering.com USD 150000 YEAR true
Director of Regulatory Affairs
Schaumburg, IL 60195 US
2023-02-23 2023-04-20 Employment Type: Permanent Job Category: Project Management Job Number: Jr379121523 Compensation: 150000
Title: Director of Regulatory Affairs
Location: Schaumburg, IL
Sterling has helped build careers for thousands of 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 the U.S.
Hire Type: Direct hire
Develop, lead, and execute the company’s 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 facilities.
- 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 level.
- 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 personnel.
- Additional duties as required.
- Bachelor’s Degree in Science or Engineering is required. Master’s Degree is preferred.
- 10+ years in a significant corporate regulatory within an FDA-regulated drugs and devices industry, with 8 years of demonstrated leadership.
- 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.