Regulatory Compliance Specialist
3 weeks ago
Job Summary
The successful candidate will be responsible for maintaining the compliance of Terumo Medical Corporation's products and processes in the changing regulatory landscape.
Key Responsibilities:
- Support the management of Health Hazard Evaluations
- Track EU MDR deliverables
- Support cross-functional project teams with compliance-related decisions and interpretations
- Evaluate the impact of standard and regulation updates on existing product families and QMS processes
- Lead the evaluation of new and revised standards and regulations for impact to products and QMS processes
- Support the TMC health hazard and recall process
- Coordinate the HHE process by engaging stakeholders to ensure timely completion
- Support the drafting, planning, execution, and gathering of information for the Critical Action Committee meeting
- Execute the recall process by drafting regulatory submission documents, coordinating reviews, and working with affiliates and recall service providers
- Support cross-functional projects as a compliance SME
- Act as an independent reviewer on design control projects to ensure compliance with internal procedures and external standards and regulations
- Provide quality system and product guidance on updated regulations and standards
- Maintain expertise in quality management standards, software, and tools applicable to Terumo Medical Corporation
- Develop and maintain expertise in applicable quality regulations
- Drive Quality System or product enhancement projects associated with regulatory changes
- Review and draft proposals to implement changes to Quality System procedures and forms
- Assist and conduct internal audits to assess compliance with applicable regulations and standards
- Assist with third-party and regulatory audits
- Perform other job-related duties as assigned
Requirements:
- Bachelor's degree in Engineering or Scientific discipline
- 3-5 years of overall experience with at least 3 years of related experience in medical devices, diagnostics, pharmaceuticals, or other regulated industries
- Strong knowledge of FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements
- Ability to communicate and interact with all levels of the organization
- Strong interpersonal skills to provide coaching, training, and direction
- Strong proofreading and writing skills, as well as exemplary attention to detail
- Strong organizational and prioritization skills
- Ability to rapidly understand complex changes and pace work completion to meet company needs
- Technical knowledge to summarize and distill complex information
- Demonstrated initiative and ability to work independently while handling multiple tasks
- Strong computer knowledge, technical writing skills, and proofreading ability
- Demonstrated ability to work effectively with cross-functional teams
Why Terumo Medical Corporation?
Terumo Medical Corporation is a leading medical device company that values innovation, quality, and compliance. As a Quality Compliance Engineer II, you will be part of a dynamic team that is committed to delivering high-quality products and services that meet the changing needs of our customers and the regulatory landscape.
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