Quality & Regulatory Affairs Specialist(Temp to Perm)
Dynamic role in fast growing Medical Device Start-up
Tremendous Flexibility to WFH
About Our Client
Our client is an oral health care company that delivers advanced, easy-to-use implants, biomaterials and planning software for dental professionals focused on providing the most functional and most aesthetically pleasing outcomes possible.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The key responsibilities of are:the Sr. Regulatory Affairs Specialist are:
- Applies knowledge of device regulatory requirements (FDA and/or other International Regulatory Agencies) to support the Post Market Surveillance MDR/ADE reporting process.
- Examine complaint data to determine trends that may result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety corrective actions/recalls related to complaints.
- Receive, review and conduct investigations of escalated product complaints or assigned product quality issues, from data collection to investigation summary, including coordinating implementation or recommendation of follow-on quality system activities
The Successful Applicant
The successful Quality & Regulatory Specialist are:
- BS Degree
- 3+ years of experience
- Experience with MDR
- Heavy experience with customer complaints and Post Market Surveillance
What's on Offer
Our client offers a base salary with strong benefits and the flexibility to work from home.