Jennifer Mering

I’m a Regulatory Affairs Specialist who supports regulatory submissions & renewals for new and existing products in the US and internationally. I ensure compliance with required regulations and established corporate standards, preparing FDA and STED submissions and maintaining regulatory product files to support audits and market release.

In my MDR & Vigilance work, I analyzed customer complaints to determine regulatory reportability, assessed seriousness and causality potential, and delivered clear, concise complaint information for MDRs and OUS regulatory reporting. I bring strong knowledge of 21 CFR part 820, 198, Complaint Files, and 21 CFR part 803, Medical Device Reporting, with disciplined documentation in global complaint handling systems.

I also strengthen cross-functional operations—updating regulatory standard operating procedures and work instructions, supporting post-market regulatory assessment of change orders and reports, and coordinating complaint processes across teams and systems. From my earlier experience supporting quality and customer care, I’m known as a steady, positive, adaptable team builder who communicates clearly, balances priorities, and trains others to keep work accurate and compliant.