Certification and Conformance Regulatory Affairs Associate (Monroe, NC)*
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About The Position
As a Certification and Conformance Regulatory Affairs Associate you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative people around the world. The person hired for this position in the 3M Personal Safety Division (PSD) will be responsible for the activities associated with certification of SCBA Respiratory Protection products to NIOSH and NFPA standards: Identifying the regulatory product certification requirements for assigned Personal Protective Equipment (PPE) portfolios and geographies. Preparing, maintaining and submitting regulatory documentation for product certification schemes applicable to PSD’s product portfolio in division and corporate systems. Actively working with appropriate test labs, notified bodies, and agencies to submit products for certification, accelerate the registration process, and arrange manufacturing site audits as required to ensure conformance of products. Collaborating with business portfolio leader(s), application engineers, quality, manufacturing and other cross functional roles to provide regulatory/compliance input into PSD new product projects and conduct regulatory assessments for new products during the commercialization process. Engaging with regulatory authorities, notified bodies, or agencies with any post-market follow-up activities or issues. Performing routine regulatory tasks for new and existing products. Keeping abreast of changes in all applicable standards and regulations/directives.
