About This Role
Supporting product development teams with regulatory inputs, strategies, and reports is the core purpose of this role. The specialist will also prepare Quality Assurance/Regulatory reports, perform research on regulatory requirements, and maintain material controls to meet various standards.
Responsibilities
- 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 and 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
Requirements
- Competent with requirements of 21 CFR Quality System Regulations/cGMPs and ISO 13485 Quality System Standard
- 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
- Proficient in scientific technical writing
- Proficient in Microsoft Word/word processing and Excel/spreadsheet
- Bachelor of Science
- One or more years of experience in Quality with medical device manufacturing background
- Experience working with ISO Quality System Standard and Quality System Regulations
- Background working in a regulated environment
Nice to have:
- Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations
- Proficiency in Access and ERP systems
- Critical thinking, facilitation, negotiation skills, and collaboration abilities
- Experience in Quality Control, Quality Assurance, or regulatory affairs
