Regulatory Affairs Specialist I Job at Freudenberg Medical LLC, Carpinteria, CA

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  • Freudenberg Medical LLC
  • Carpinteria, CA

Job Description

Responsibilities arrow_right

  • Performs regulatory impact assessments for manufacturing and product changes for notification to regulatory agencies
  • Prepares regulatory plans, prepares needed regulatory submissions and maintains associated documents for FDA, Health Canada, MDR, Notified Bodies, and ROW countries and secure approvals
  • Go to person for cross functional team to elaborate and align on regulatory tasks and required documentation
  • Conducts training programs to educate employees on regulatory processes and requirements
  • Communicates with regulatory agencies regarding clarification of and follow-up of submissions under review
  • Assesses product, manufacturing and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance to regulations.
  • Reviews technical reports for incorporation into regulatory submissions
  • Maintains company registration and device listings for global regulatory agencies
  • Regulatory liaison/representative in internal and external audits
  • Maintains current knowledge base of existing and emerging regulations, standards and guidance documents
  • Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
  • Prepares and maintains technical files as necessary to obtain and sustain product approvals
  • Management of international standards, directives and regulations for gap impact analysis. This includes implementation of procedural and documentation updates, when necessary.

Qualifications arrow_right

  • BS degree (preferably in Regulatory Sciences/Practices, etc.) or equivalent experience with certified RA coursework/seminars
  • 3 - 5 years of medical device Regulatory Affairs experience with a track record of successful submissions
  • Experience preparing & defending regulatory submissions to the FDA (510(k), Qsubs, IDE’s, EU MDR technical files,
  • Detailed knowledge of global regulatory requirements.
  • Proven track record with regulatory submissions.
  • Energetic, positive self-starter with a strong proficiency to self-manage and work collaboratively in a high-performing team and cross-functional fast-paced environment
  • Outstanding written and verbal communication skills
  • Keen ability to prioritize work and execute in an environment of competing priorities
  • Strong organizational skills
  • Strong technical/computer skills
  • Willingness and ability to travel to Carpinteria, CA, per business need about 25%

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