21-0080 Regulatory Affairs Coordinator (Quality Assurance)

Streck is recruiting for a Regulatory Affairs Coordinator within the Regulatory Affairs area. This position will be responsible for supporting global and domestic regulatory compliance at Streck. The areas of responsibility include assistance with international and domestic regulatory submissions, coordination of risk management activities and design control process support. This position will also perform other duties assigned by manager.

The primary responsibilities include:

• Identify and coordinate data collection requirements for regulatory submission, new products and / or changes to existing products. Complete associated statistical analyses and reports.
• Assist in the completion and management of domestic and international IVD submissions/technical files.
• Assist with Design Control project coordination and support as required.
• Serve as Regulatory review for printed materials as required.

Requirements include:

• Bachelor's degree in a business or science-related discipline.
• Four years of experience participating in project management teams preferred
• Sound knowledge of good manufacturing practices (GMP) and FDA regulations affecting medical devices (QSR).
• Understanding of ISO, EU and CMDR Quality System requirements and conditions.
• Ability and willingness to learn Domestic and International Product Registration requests (IVD)

Visit to learn more about Streck and apply for this opportunity.

Streck develops and delivers quality control and diagnostic products that touch millions of lives and help validate the reputations of laboratories, hospitals and clinicians all over the world.

For all of us at Streck, our job is not simply about scientific accuracy. It is just as much about responsiveness, commitment and responsibility. The result is something science alone cannot create: Trust.

Streck is located in a state-of-the art facility just minutes from Interstate 80 in the southwest Omaha/LaVista area. We offer a collaborative environment with career advancement opportunities, competitive pay, comprehensive benefits, work/life balance and corporate wellness focus.

Streck is an Equal Opportunity/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver 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, state and local laws.