Job Details

Summary

Responsible for supporting the company's regulatory strategies by assisting with regulatory submissions, change assessments, labeling, regulatory intelligence and regulatory reporting. Will work collaboratively to assist with compliance to FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Responsibilities

Regulatory Applications

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Reviews protocols and reports to support regulatory submissions.
• Using project management techniques, facilitates interdepartmental coordination to help track and monitor progress towards completion of regulatory submissions

Change Assessments

• Perform regulatory assessment of changes to identify regulatory reporting requirements and to ensure adequate information is included.
• Support the System Change Request Process (SCR Process).

Labeling

• Reviews and provides input on device labeling
• Reviews and evaluates communications to ensure communications convey all necessary details and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.

Regulatory Intelligence

• Maintain listing of applicable External International Standards with collaboration from other functional areas.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.

Regulatory Reporting

• Participates in quality system processes that require assessments for regulatory reporting.
• Prepares required progress and annual reports for regulatory agencies

Other duties as assigned.

Qualifications

Essential Qualifications: (includes education, background skills & expertise)

• Education

  Bachelor of Science Degree

  
  

• Experience

  5+ years of experience with medical device regulatory affairs (preferred), but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

  
  

• Skills:

oWorking knowledge of FDA IDE regulation

oStrong written and verbal communication skills to serve as regulatory liaison

oStrong proficiency with MS office applications, including MS Word, MS Excel and MS PowerPoint

oAbility to organize information methodically with meticulous attention to detail

oCapacity to summarize engineering and clinical information suitable for regulatory agency review

oProject management experience, including tracking of deliverables and due dates

Desirable Skills

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Familiarity with EU MDR Directive

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Knowledge of cardiac pacing and/or defibrillation or other cardiac medical devices

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Project management

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Certification (such as RAC from the Regulatory Affairs Professionals Society.)

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Preferred US FDA Class III device experience