Senior Regulatory Affairs Associate

2 months ago

Eden Prairie, United States Elucent Medical, Inc. Full time

Job Title:

Senior Regulatory Affairs Associate

Reports to:

Vice President – RA and QA

EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS

BA/BS degree (preferably in Regulatory Sciences)

Minimum 5 years of medical device Regulatory Affairs

Proven track record with regulatory submissions.

Experience preparing & defending regulatory submissions to the FDA (510(k)

Knowledge of global regulatory requirements including EU, Canada and Asia.

Demonstrated experience of basic engineering principles; electrical, mechanical and software

Proven effective collaboration with regulatory agencies

Ability to apply critical thinking on current global regulatory science questions.

Individual must have a hands-on approach

Strong organizational and time management skills

Excellent technical/computer skills

REQUIRED COMPETENCIES

Leadership:

Recognized as a technical leader within the company and maintains positive attitude when working with peers, customers or suppliers

Capable of leading a project team in fulfillment of regulatory requirements for a given product and/or geography

Works effectively on cross functional teams

Communication

Excellent written and oral communication skills

Ability to formulate responses to common inquiries from regulatory agencies

DESCRIPTION OF RESPONSIBILITIES

The Senior Regulatory Affairs Associate will support the definition of the regulatory strategy for Elucent products. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. The successful candidate should possess a scientific background and will have an understanding of electromechanical devices. The ability to deal with ambiguity and think outside the box are critical for this position.

KEY RESULT AREAS

  • Regulatory lead/representative on project core teams providing regulatory input on all matters
  • Leads preparation, documentation and submission of FDA and other international applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes.
  • Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
  • Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA and other country-specific regulations as required.
  • Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.
  • Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.
  • 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
  • Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced.
  • Maintain current knowledge of relevant regulations and guidelines both proposed and final rules.
  • Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
  • Support post-approval products through change evaluation and submission.

Other duties as assigned.

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