Overview
- Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization.
- Collects all materials required in submissions, license renewal, and annual registrations.
- Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies.
- Works on problems of complex scope where data analysis requires evaluation of specific factors.
- Utilizes independent judgment within broad parameters to determine an appropriate solution.
- May determine methods and procedures on new projects and may provide guidance to other lower-level staff.
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
- Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
- Job requires an understanding and application of procedures and concepts of own discipline.
- The job requires the ability to make judgements based on practice and previous experience.
- This job typically requires a degree or equivalent and no experience.
Required:
• 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 and 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: Remote
