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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