Regulatory Affairs Manager
ABOUT STRECK
Streck is a privately held company dedicated to producing high-quality cell stabilization products and controls for the hematology, flow cytometry, and molecular industries used by laboratories around the world. At Streck, we are driven by our core values and a commitment to quality in everything we do. Join a team where your expertise directly supports making an impact in healthcare.
POSITION OVERVIEW
We are seeking an experienced Regulatory Affairs Manager to ensure Streck remains compliant with all necessary regulatory requirements for the development, approval, manufacturing and marketing of products. This pivotal leadership role will collaborate with Quality Assurance and Quality Control teams to ensure the Quality System meets ISO, FDA, and all applicable international regulatory requirements, while supporting the overall business goals of the organization. The role will partner closely with Quality Assurance, Research & Development, and executive leadership to cultivate a culture of quality, continuous improvement, and regulatory excellence.
ESSENTIAL DUTIES & RESPONSIBILITIES
Regulatory Compliance & Strategy
- Manage and ensure regulatory compliance for the organization.
- Provide guidance and interpretation of global regulatory requirements while balancing compliance withmultiple regulatory systems.
- Evaluate product and process changes and deviations for risk and regulatory compliance.
- Continuing review and evaluation of existing processes for compliance, efficiency, consistency, and effectiveness.
Regulatory Submissions & Agency Interaction
- Manage the preparation and submission process of regulatory submissions, including 510(k)s and other required filings, to obtain approval for new products.
- Provide regulatory support for marketed products throughout their lifecycle.
- Interact directly with regulatory agencies and health authorities to resolve matters and expedite the approval process.
- Review labeling and advertising to ensure compliance with FDA regulations.
- Lead new country registrations to help expand Streck’s market presence.
Quality Management System Regulation (QMSR)
- Collaborate with QA to ensure effectiveness and suitability of the QMSR and interpret requirements.
- Ensure effective regulatory implementation, reporting, and training supportive of the QMSR.
- Review and approve product/process change control reports, validations, risk reports and design control protocols.
Leadership & Cross-Functional Collaboration
- Develop and administer department budget; perform general department management functions including leadership and staff development in regulatory affairs.
- Provide guidance and coordination for joint QA/QC efforts.
- Serve on design teams and collaborate with Research and Development for design control activities.
- Serve as a member of management and functional teams and committees deemed appropriate.
Risk Management & External Relations
- Manage Streck's Risk Management program.
- Correspond with Authorized Representatives, Registrars, Customers, and other Key stakeholders to ensure compliance.
POSITION REQUIREMENTS
- Bachelor's degree in biological sciences, bioengineering, and/or a related medical or health field (preferred).
- 5–8 years of experience in regulatory affairs and/or quality within a GMP and/or ISO regulated environment.
- 3 years of direct people management experience.
- Experience writing or completing regulatory submissions (510(k)s and similar).
- Working knowledge of global medical device regulations.
- Above-average oral and written communication skills.
- Demonstrated project management skills.
KEY COMPETENCIES
- Effective Decision Making — Analyzes problems, generates multiple solutions, and makes high-quality decisions under time pressure.
- Change Agility — Embraces and leads change; adapts quickly and continuously seeks self-improvement.
- Leads Teams — Develops high-performing teams, establishes clear goals, and coaches team members.
- Strategic Awareness — Aligns objectives with company strategy; understands complex business interrelationships and global industry trends.