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- 1-year contract with possibility to extend, starting ASAP
- On-site in Alameda, CA
- Pay Rate: Up to $40-48/hr based on experience ($80-96k)
- FT hours, M-F 8a-5p
- Business Unit: Diabetes Care
- Interview Process: 1 interview with hiring manager and then interview with manager's leadership
- Identify gaps in processes or product design (documentation)
- File necessary applications and handle all government interactions regarding the regulation process for products requiring governmental approval
- Review/approve engineering study protocols/reports and validation study protocols/reports
- Review and assess emerging regulations
- Recent experience with medical device design controls ideal
- Understanding of engineering change control process
- Familiarity with Agile PLM system
- May require an advanced degree and 2-4 years of direct experience in the field
- Relies on analytical thinking and judgment to plan and accomplish goals
- A wide degree of creativity and latitude is expected
- Open to Engineering, Quality, or Manufacturing backgrounds who are interested in a career in Regulatory Affairs
Regulatory Affairs Associate - Alameda, United States - GForce Life Sciences
Description
Regulatory Affairs Associate - On-site in Alameda, CA
Term & Start
Summary
This role would work in the Emerging Regulations team of the Diabetes Care Division, managing narrow and specific regulations with cross-functional teams. The ideal candidate will have strong analytical skills, proactive communication skills, and strong organizational and documentation skills.
Day-to-Day Duties
Qualifications