Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Senior Post Market Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: $100-105K
- Job Location: Waltham, MA
- Job# bh12431
Senior Post Market Specialist
Job is onsite
We are looking for a Senior Post Market Specialist to join our Quality team in Waltham, MA. In this role, you will be a senior member of a collaborative team, working to maintaining the Complaint Handling database and make process improvements to assure compliance to applicable regulations and requirements.
This is an opportunity to leverage your deep knowledge of post market and contribute to a company that has an impact in peoples’ lives around the world. Our product catalog is comprised of state-of-the-art technologies currently being in the clinical treatment of COVID-19 patients and by major biotherapeutic companies for vaccine development.
Highlight of responsibilities include:
- Take lead role and contribute to projects to develop and update policies and procedures, in collaboration with peers and manager
- Evaluate effectiveness of current processes through KPIs and risk assessment
- Monitor and ensure timeliness of all complaints process and reporting activities in accordance to procedures, standards and regulations
- Mentor team members to follow established complaint process and ensure compliance as outlined by practices and state/federal guidelines.
- Conduct compilation, analysis and reporting of post-production information as part of the Post-Market Surveillance system
- Bachelor’s degree or equivalent experience
- 5+ years of experience in post market / complaint handling role in medical device/ diagnostic industry, including previous responsibility to submit Medical Device Reports (MDRs) and/or adverse events to regulatory agencies.
- Working knowledge of most regulations relative to PMS activities and reporting, such as ISO 13485, ISO 14971, FDA Regulations (21CFR (803,806,82, etc.)), CMDR, JPAL, IVDD/IVDR
- Solid computer skills, including MS Word, Excel and PowerPoint
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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