Director Regulatory Affairs
Job Description
- 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.
Qualifications:
- 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.
Meet Your Recruiter
Mike Schmitz
Technical Recruiter
Mike Schmitz is an esteemed Recruiting Team Leader specializing in the Life Sciences Division. With an impressive tenure of over 12 years at Sterling and a remarkable 16-year career in the recruiting arena, Mike has cemented his reputation as a trailblazer in talent acquisition.
As a Recruiting Team Leader, Mike's understanding of the intricacies within the Life Sciences Division is unparalleled. His expertise positions him as a strategic partner in bridging the gap between talented professionals and opportunities that align with their aspirations.
With a career spanning 16 years, Mike's journey in the recruitment landscape has been defined by his dedication to facilitating more fulfilling careers for skilled professionals. His ability to understand everyone’s unique strengths and match them with roles that foster growth and satisfaction marks him as a true advocate for professional development.
Mike's advice to candidates reflects his commitment to helping them excel: approach every job interview with positivity and authenticity. He firmly believes that a positive attitude and an engaging personality are pivotal in creating lasting impressions. Mike emphasizes that while technical qualifications are crucial, the ability to connect with interviewers and present oneself effectively is equally valuable to prospective employers.