Medical Device Regulatory Specialist - post market

Company: LEDGENT Technology & Engineering - Roth Staffing C
Location: San Jose
Posted on: October 17, 2024

Job Description:

Medical Device client is seeking a Sr. Regulatory Affairs Consultant for a remote 18 month contract!Duration: 18 MonthsLocation: REMOTEMax Pay: $100Required:

• Bachelor's degree required, engineering or science degree preferred.What you will do:
• Review reports of customer complaints and assess them for regulatory reporting.
• Submit initial and follow-up reports to device related agencies as appropriate.
• Process Additional Information (AI) request letters from regulatory agencies.
• Analyze complaint data.
• Work with customers and sales forces to resolve complaint issues.
• Interact with device related Agencies on vigilance reports and incidents.
• Recommend corrective and/or preventive actions to address non-conformities and deviations.
• Work and train other departments on their complaint handling responsibilities.
• Assist in developing solutions and processes to manage complaints.
• Maintain current on TrackWise system.
• May review and approve non-conformances and planned deviations.
• May aid in developing and executing process and product protocols and reports.
• May provide backup phone support to the complaint hotline.
• May work with pre-market Regulatory personnel in developing post-market product requirements.
• Support management of high-level projects and initiatives, with responsibilities that include defining, managing and executing project charters and partnering with cross-functional groups to establish roles, responsibilities, and deliverables.
• Capable of clearly identifying, analyzing, and understanding potential risks and problems and work with management to assure the appropriate actions are taken.
• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and support process improvement initiatives to maximize efficiencies.Preferred:
• Experience working in medical device, biologics and/or pharmaceutical field preferred.
• Proficient in Microsoft Office, Excel and PowerPoint.
• Knowledge of applicable international regulations and standards (CFR, EU MDR, QSR, ISO 13485, MDSAP, etc.).
• Ability to interface with both technical and non-technical personnel at all organizational levels.
• Technical writing experience preferred.
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
• Regulatory Affairs Certification and/or ASQ Certification preferred.
• Prior experience working in a virtual/remote environment with demonstrated capabilities to work with minimal supervision.Work Flexibility: RemoteAll qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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Keywords: LEDGENT Technology & Engineering - Roth Staffing C, Salinas , Medical Device Regulatory Specialist - post market, Healthcare , San Jose, California