Streck
Regulatory Affairs Manager
La Vista, Nebraska
Sponsorship not specifiedDetected 60 days ago
ComplianceProject ManagementGMPFDA RegulatoryFlow CytometryMedical DevicesResearchLeadershipCommunicationCollaborationRegulatory Affairs
About the role
- The role will partner closely with Quality Assurance, Research & Development, and executive leadership to cultivate a culture of quality, continuous improvement, and regulatory excellence.
- 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.
Responsibilities
- Manage and ensure regulatory compliance for the organization.
- Provide regulatory support for marketed products throughout their lifecycle.
- Lead new country registrations to help expand Streck's market presence.
- Review and approve product/process change control reports, validations, risk reports and design control protocols.
- Develop and administer department budget; perform general department management functions including leadership and staff development in regulatory affairs.
- Collaborate with QA to ensure effectiveness and suitability of the QMSR and interpret requirements.
- Serve on design teams and collaborate with Research and Development for design control activities.
- Manage Streck's Risk Management program.
- Streck is a Nebraska-based manufacturing company that makes a global impact by developing and distributing to labs worldwide.
Requirements
- 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).
- Manage the preparation and submission process of regulatory submissions, including 510(k)s and other required filings, to obtain approval for new products.
Benefits
- Our products provide confidence for accurate health care testing!
- Interact directly with regulatory agencies and health authorities to resolve matters and expedite the approval process.
Company info
- 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.
- Correspond with Authorized Representatives, Registrars, Customers, and other Key stakeholders to ensure compliance.
- Our passions and priorities are focused on taking care of our customers, employees, and giving back to our community.
Visa & Work Authorization
- ver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, st
This listing is sourced directly from Streck's careers page and normalized into a canonical job model.