Junior Regulatory Affairs Specialist

Job Summary

Supports tasks related to Regulatory and Compliance activities including tasks to ensure compliance during product development activities, local, state, federal and any outside US requirements.

Supports activities to ensure products consistently meet or exceed established compliance and quality standards. Ensure that processes and work practices are compliant to applicable local, state, federal, international regulations and customer requirements pertaining to medical device and medical device manufacturing, worker health and safety, and environmental protection. Support/execute planned facility and product development RA strategies. Responsibilities include support for QA/RA related operational activities within the Quality System that may include processes such as recall investigations/activities, Audits, Deviations and Process/Product Validations and Product Development/Design Control deliverables.

• 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.
• Assess/notify management of changes or new regulatory requirements; collaborate on their application within the QMS, product markets, or products
• Prepare a variety of written correspondence and documents.
• Perform other duties as assigned.

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.

• Provide deliverables for Regulatory and Safety compliance including reports. Must provide accurate and complete deliverables on time.
• Self starter and can research internal, customer and regulatory requirements without prompt to ensure deliverables are on time, accurate and meets requirements.
• Ascertain integrity of procedures.
• Ensure that work is being performed in accordance with documented procedures.
• Seek to improve and make changes in procedures to document “best practices”.
• Keep up with all regulations and stay informed of organizational changes.
• Remain well prepared for audits by external agencies/organizations (including, but not limited to FDA, ISO, EPA, OSHA).
• Sustain safe work environment.

Bachelor of Science. Experience preferred 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.…