BIOMERIEUX, INC.
Sr. Regulatory Compliance Engineer
BIOMERIEUX, INC., Salt Lake City, Utah, United States, 84193
Sr. Regulatory Compliance Engineer
Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Engineering
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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description 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 ProcessElectrical EngineeringMechanical EngineeringMicrosoft Tools (Word, PowerPoint, Excel, Visio, Teams)Project ManagementCross-functional team communicationElectromagnetic CompatibilityElectrical SafetyWorking knowledge of the following standards preferred:RoHS/REACHULCEIEC 61010IEC 60601IVDRWEEE
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, the se scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out... For full info follow application link.
#AdvancedManufacturing
Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Engineering
Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin
Apply Now >
A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description 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 ProcessElectrical EngineeringMechanical EngineeringMicrosoft Tools (Word, PowerPoint, Excel, Visio, Teams)Project ManagementCross-functional team communicationElectromagnetic CompatibilityElectrical SafetyWorking knowledge of the following standards preferred:RoHS/REACHULCEIEC 61010IEC 60601IVDRWEEE
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, the se scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out... For full info follow application link.
#AdvancedManufacturing