Regulatory Affairs Manager

Reports to: Director of Quality & Regulatory Affairs Direct Reports: 3 Regulatory Affairs Specialists Travel: Approximately 5-10% Compensation: $95,000 - $142,500 base + 15% bonus Lucas James Talent Partners has been retained by Streck to lead the search for a Regulatory Affairs Manager. This is a direct-hire leadership opportunity within Streck's Quality organization. About Streck For more than 50 years, Streck has been a global leader in the development and manufacturing of innovative products that support clinical laboratories, diagnostic manufacturers, and healthcare providers worldwide. Serving customers in more than 100 countries, Streck develops products that improve the quality, accuracy, and reliability of diagnostic testing while maintaining a strong reputation for scientific innovation, regulatory excellence, and operational quality. As the organization continues to expand its global regulatory footprint, Streck is investing in leadership that will strengthen its regulatory infrastructure, support international growth, and help position the business for continued success. The Opportunity This is not a traditional Regulatory Affairs Manager role focused primarily on maintaining compliance. This is an opportunity to inherit a stable, experienced Regulatory Affairs team while helping define how the function supports Streck's next phase of global growth. Reporting directly to the Director of Quality & Regulatory Affairs, this leader will manage three experienced Regulatory Affairs Specialists while serving as one of the primary regulatory leaders supporting Streck's global product portfolio. Success in this role will come from building greater structure, visibility, and consistency across Regulatory Affairs while partnering closely with Quality, R&D, Quality Control, Sales, Distribution, and business leadership to guide regulatory strategy across global markets. The Mandate Build Structure Across Regulatory Affairs Build scalable regulatory processes and playbooks supporting global registrations and submissions. Improve visibility, prioritization, and consistency across Regulatory Affairs. Strengthen cross-functional collaboration throughout the organization. Lead Global Regulatory Strategy & Execution Lead complex regulatory submissions including 510(k), De Novo, PMA, MDR, IVDR, and international product registrations. Evaluate regulatory pathways while balancing regulatory risk and business objectives. Guide regulatory strategy for new products in partnership with Quality, R&D, and business leadership. Serve as the primary escalation point for the Regulatory Affairs team. Develop a High-Performing Team Lead, coach, and develop three experienced Regulatory Affairs Specialists. Build processes, tools, and resources that strengthen team capability and long-term performance. Serve as a Strategic Business Partner Partner regularly with Quality, R&D, Quality Control, Sales, Distribution, Channel Partners, International Assay Partners, and regulatory agencies while serving as one of Streck's primary regulatory resources supporting innovation and global expansion. The Profile We are seeking a leader who is: A Global Regulatory Expert Has successfully led complex regulatory submissions and international registrations across multiple jurisdictions. A Strategic Decision Maker Can evaluate regulatory pathways, assess risk, and provide practical recommendations that support both compliance and business objectives. Builds strong relationships across technical and commercial teams while influencing through credibility, communication, and sound regulatory judgment. A Team Developer Enjoys coaching others, developing talent, and building structure that enables high-performing teams. Comfortable Navigating Ambiguity Thrives in evolving environments and makes thoughtful regulatory decisions when the answer is not always black and white. Scientifically Curious Brings a strong scientific foundation and enjoys working with technically complex diagnostic products. Compensation 15% Bonus What You Bring We're seeking an accomplished Regulatory Affairs leader with the technical depth, business acumen, and proven people leadership experience to guide a seasoned team and influence regulatory strategy across a growing global organization. Required Bachelor's degree in Biological Sciences, Bioengineering, Medical Laboratory Science, or another life sciences or STEM-related discipline. An advanced degree is a plus. 5-8 years of progressive Regulatory Affairs experience within a GMP and/or ISO-regulated medical device environment, including close partnership with Quality. Minimum of 3 years of direct people management experience leading experienced technical professionals, with a track record of performance management, coaching, talent development, and building high-performing teams. Demonstrated success leading complex regulatory submissions, including FDA pathways such as 510(k), De Novo, PMA, and international frameworks including MDR, IVDR, MDSAP, Health Canada, or comparable global regulatory systems. Proven experience developing regulatory strategy and evaluating multiple regulatory pathways while balancing compliance, business objectives, cost, and time-to-market. Demonstrated ability to interpret complex global regulatory requirements and translate them into practical business decisions. Proven ability to manage multiple global regulatory priorities while balancing business objectives, regulatory risk, and evolving timelines. Strong understanding of FDA Quality System Regulations (QSR), ISO 13485, global medical device regulations, and international registration requirements. Experience partnering cross-functionally with Quality, R&D, Manufacturing, Commercial teams, and executive leadership. Exceptional written and verbal communication skills with the ability to influence technical and business stakeholders across the organization. Preferred Experience within IVD, diagnostics, or the broader medical device industry. Experience leading international registrations and interacting directly with FDA reviewers, notified bodies, and global regulatory agencies. Experience developing Regulatory Affairs processes, playbooks, Design Controls, Risk Management, Change Control, Quality Management Systems, or supporting OEM/private label product launches. Why Join Streck? This is an opportunity to join an organization known for scientific innovation while helping shape the future of a highly respected Regulatory Affairs function. You'll have the opportunity to: Lead a stable, experienced Regulatory Affairs team. Build regulatory processes and playbooks supporting future global growth. Influence regulatory strategy across an expanding international product portfolio. Partner directly with senior leadership on complex global regulatory initiatives. Continue your own professional development through leadership training and Regulatory Affairs conferences. Make a lasting impact on how Regulatory Affairs supports the broader business. Success in This Role Build greater structure, visibility, and consistency across Regulatory Affairs while developing scalable global regulatory processes and playbooks. Become a trusted advisor to Quality, R&D, Sales, and executive leadership, helping position Streck for continued international growth and innovation. Equal Opportunity Employer Streck is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other protected characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr Streck