Regulatory Affairs Coordinator

Streck Provides

• A challenging, safe and rewarding work environment.
• No night or weekend shifts.
• Excellent work life balance. 
• Affordable, high-quality apartments for employees.
• Market competitive pay.
• Comprehensive and inclusive benefits.
• Great team environment.
• On and off campus career development opportunities.

Summary of Responsibilities

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 the manager.

Essential Duties and Functions

1. Serve as the corporate contact for International Registrations by gathering documentation, obtaining legalization/apostille information, and communicating with distributors, private label accounts, and other corporate partners regarding international registration.
2. Provide corporate guidance on domestic and international Unique Device Identification (UDI) requirements.
3. Provide assistance in product and manufacturing process changes for regulatory impact to international registrations requirements.
4. Provide support data and rationale if necessary.
5. Create, modify, and / or update finished product SDS as required.
6. Identify and coordinate data collection requirements for regulatory submission, new products and / or changes to existing products. Complete associated statistical analyses and reports as required.
7. Assist with Design Control project coordination and support as required.
8. Serve as Regulatory review for printed materials as required.
9. Assist in the completion and management of domestic and international IVD submissions/technical files. Participate in Underwriters Laboratories  (UL) filings as required and act as a liaison when assigned.
10. Review proposed permanent product, process, or manufacturing changes process for effect on regulatory requirements.
11. Participate in Supplier and Internal Audit programs as assigned.
12. Perform all other duties as assigned by management.

Position Requirements

• Bachelor’s degree in a business or science-related discipline.
• Four years of experience participating in project management teams preferred.
• Four years of experience in the implementation of process improvement efforts.
• Four years of related experience in an FDA regulated manufacturing environment preferred.

Technical Competencies

• 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).
• Strong PC skills and knowledge of word processing, spreadsheet, and database applications
• Experience in quality system auditing and change management preferred.

Work Environment/Travel Demands

The work environment is a climate-controlled biological/chemical laboratory. Occasional short durations to cold temperatures inside walk-in coolers. Ability to wear required laboratory clean room clothing (laboratory coats, hair bonnets, and beard covers (as applicable) and other safety/protective equipment (masks, gloves, and/or face shields for example) for up to two and a half hours consecutively. Travel demands for this position are estimated up to 0%. If travel is required, this travel may include customer visits, events/trade shows, and completion of presentations primarily throughout Domestic US or International regions. Employees must comply with all travel recommendations regarding “safe travel” according to company policies and guidelines, and all federal, state, local, and international orders.

Physical and Mental Demands

Light work exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or up to 5 pounds of force constantly to move objects. This also includes standing for up to two and a half hours consecutively, walking, pushing, pulling, lifting, reaching, stooping, fingering, and grasping. Expressing and receiving detailed information through written and oral communication. Also has an ability to make sound, appropriate, and prompt decisions within the guidelines of the role.

**The work environment characteristics and physical demands stated in their respective sections are representative of those necessary to perform the essential functions of the job. Reasonable accommodations will be reviewed and considered. If approved, accommodation may be made to enable individuals with disabilities to perform the essential functions of their assigned role.

The above statements are intended to describe the general nature of work being performed by people assigned to this classification.â?¯They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Visit www.streckcareers.comâ?¯to learn more about Streck and apply for this opportunity. 

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.