Sr. Regulatory Affairs Specialist in Irvine, CA at Johnson Service Group

Date Posted: 1/4/2022

Job Snapshot

Job Description

JobID: 387351

Johnson Service Group is currently seeking a Regulatory Affairs Specialist for our Client in Irvine.

This individual will be Responsible for Regulatory and Compliance activities including tasks to ensure compliance with local, state, federal, any outside US requirements, and during new product development activities.

They will support activities to ensure products consistently meet or exceed established compliance and quality standards. Ensure that processes and work practices are compliant to applicable regulations and customer requirements pertaining to medical device and medical device manufacturing, and where appropriate, environmental requirements. Determine facility and product development RA strategies. Responsibilities include support for QA/RA related operational activities within the Quality Management System that may include processes such as recall investigations/activities, Audits, and Product Development/Design Control deliverables.

JOB DUTIES:

  • License renewals, updates and registrations including device listings, 510(k), GUDID, MAUDE, EUDAMED, OC Health, DTSC, etc.
  • Support product and facility licenses, listings, technical file submissions. Support/fulfill requirements related to CAFDB, USFDA, EU MDD, Health Can, OSHA, DTSC, OC Health, and other regulating agencies.
  • Collect and coordinate information and prepare regulatory documentation to regulatory agencies and customer partners.
  • File necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Prepare, support, and maintain deliverables for 510K and CE Marking (Technical Files) submission documents and maintain records.
  • Review/approve changes for new and revised labels, labeling, marketing and website.
  • Review changes to existing products and SOPs to ensure compliance is maintained.
  • Assess regulatory issues and new requirements, determine their application within the QMS, product markets, or products and dissemination to management/functional teams.
  • Assist in developing procedures to ensure regulatory compliance.
    Support Product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables.
  • Prepare reports and documents necessary regulatory deliverables within Design Controls and, where contractual, in support of customer QA/RA needs.
  • Advise on regulatory strategy
  • Support internal, agency and customer audits.
  • Support safety inspection findings.
  • Maintain and support material controls and deliverables to ensure requirements of RoHS, REACH, Conflict Minerals and Prop 65 are fulfilled.
  • Maintain current procedures.
  • Prepare a variety of written correspondence and documents.
  • Perform other duties as assigned.

SKILLS AND QUALIFICATIONS:

  • competent with requirements of 21 CFR Quality System Regulations/cGMPs, ISO 13485 Quality System Standard and EU Medical Device regulations.
  • Ability to research, write and support regulatory strategies and supporting documentation/reports.
  • Knowledgeable and proficient in creating/reviewing clinical and biological studies relating to establishing/satisfying regulatory requirements, product equivalency and safety.
  • Ability to analyze trends and draw logical conclusions. 
  • Proficient in scientific technical writing.
  • Ability to work with mathematical concepts such as probability and statistical inference to apply concepts to practical situations. 
  • Critical thinking, facilitation, negotiation skills and collaboration abilities.
  • Proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills. 
  • Proficiency in Access and ERP systems a plus.

ACCOUNTABILITIES:

  • 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 Customers, FDA, ISO/Notified Body, OC Health, UL, EPA, OSHA).
  • Sustain a safe work environment.

EDUCATION AND EXPERIENCE:

  • Bachelor of Science.
  • Four or more years established within Regulatory Affairs in Medical Device industry.
  • Medical device manufacturing/operational background a plus.
  • ISO Quality System Standard and Quality System Regulations.
  • Experience in industrial hygiene/safety, government regulations, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.
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