Regulatory Affairs Specialist

Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables. Prepare Quality Assurance/Regulatory reports and present status in review meetings. Prepare reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs. Perform research to determine Regulatory requirements of product markets & product requirements.

Support internal, agency and customer audits and any resulting nonconformity / improvement actions. Support safety inspection findings. Support recurring and new product and facility licenses, listings, technical files, submissions. Maintain and support material controls and deliverables to meet requirements of RoHS, REACH, Conflict Minerals, Prop 65, and other applicable material controls. Support/fulfill requirements related to CAFDB, USFDA, EU MDR, UK MDR, Health Canada, OSHA, DTSC, OC Health, and other regulating agencies.

Maintain current procedures. Prepare and support deliverables for 510K and CE Marking submission documents and maintain records.

• Must be competent with requirements of 21 CFR Quality System Regulations/cGMPs and ISO 13485 Quality System Standard.
• Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations a plus.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to research, write and support regulatory strategies and supporting documentation/reports.
• Ability to analyze trends and draw logical conclusions.
• Must be proficient in scientific technical writing.
• Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills. Proficiency in Access and ERP systems a plus. Critical thinking, facilitation, negotiation skills and collaboration abilities essential.
• Bachelor of Science. Experience preferred in in Quality Control, Quality Assurance or regulatory affairs.
• One or more years of experience in Quality with medical device manufacturing background.
• Must have experience working with ISO Quality System Standard and Quality System Regulations.
• Must have background working regulated environment. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.