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.

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.

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.

• 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 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.

• Lead, coach, and develop three experienced Regulatory Affairs Specialists.
• Build processes, tools, and resources that strengthen team capability and long-term performance.

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.

We are seeking a leader who is:

Has successfully led complex regulatory submissions and international registrations across multiple jurisdictions.

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.

Enjoys coaching others, developing talent, and building structure that enables high-performing teams.

Thrives in evolving environments and makes thoughtful regulatory decisions when the answer is not always black and white.

Brings a strong scientific foundation and enjoys working with technically complex diagnostic products.

• 15% Bonus

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.

• 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…