This regulatory compliance engineer works within the various engineering teams at bioMerieux to provide leadership and technical guidance relating to regulatory compliance activities. Collaborates with research, development, released product design teams, regulatory affairs, and other departments in the organization to analyze complex issues, modify working methods, apply technical expertise in order to ensure compliance with new products, prevent compliance issues with released products, and collaborate with these teams to execute compliance programs in accordance with bioMerieux’s quality system.
Primary Duties:
- Creating and maintaining compliance technical protocols, in conjunction with subject matter experts, and reviewing with engineering management.
- Identify, define and develop solutions to issues and problems that are not immediately evident in existing systems or process.
- Creating and maintaining technical compliance general policies relating to engineering development and sustainment.
- Perform all work in compliance with company quality procedures and standards.
- Ensures compliance of new products via collaboration with development teams, including review of technical data, identifying and resolving short and long term product and engineering design issues.
- Researching and identifying applicable regulatory and industry compliance standards and codes.
- Document compliance via test report generation, analyzing and evaluating results, and working with teams to create declarations of conformity.
- Work with engineering team to troubleshoot and resolve compliance failures.
- Ensuring up to date knowledge of technical standards by tracking and understanding emerging compliance standards and best practices; training various teams in the engineering organization and company on this knowledge as applicable.
Training and Education:
Bachelor’s Degree. Engineering degree or experience preferred.
Experience:
10+ years’ experience in a regulatory environment with at least 5+ years’ experience being in a technical role, recommended.
Knowledge, Skills, Abilities:
- Experience with the following is preferred:
- Engineering Development Process
- Electrical Engineering
- Mechanical Engineering
- Microsoft Tools (Word, PowerPoint, Excel, Visio, Teams)
- Project Management
- Cross-functional team communication
- Electromagnetic Compatibility
- Electrical Safety
- Working knowledge of the following standards preferred:
- RoHS/REACH
- UL
- CE
- IEC 61010
- IEC 60601
- IVDR
- WEEE
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