Vigilance Reporting And Safety Board Principal

Job Responsibilities - 80%

Remote based position

• Responsible for Medical Device Vigilance program, including but not limited to, ensuring potentially reportable incident /potential safety incident criteria is maintained/updated at the divisional level.
• Responsible for the global adverse event reporting (AER) program, including but not limited to, Medical Device Reporting assessments and submissions, Manufacturer Incident Report assessments, communications to regulatory authorities, represent Quality in Product Care Quality Teams.
• Accountable for ensuring recall processes adhere to global regulations and internal procedures. Ensures corrections, removals and recalls are managed effectively and efficiently including ensuring regulatory compliance and technical accuracy for all necessary recall documentation (i.e. 21 CFR 806, Urgent Medical Device Correction, Field Safety Corrective Action, etc.)
• Leads Health Hazard Evaluation (HHE) activities with collaboration from Technical SMEs and Medical & Scientific Affairs.
• Supports decision making for Health Hazard Assessments, Vigilance Reporting, CAPA, and Recalls based on analysis and trending of post-market data sources.
• Coordinates, monitors, and analyzes trending of Recall and Adverse Event Reporting data for Site Management Review Meeting (SMR).
• Responsible for managing compliance communications with regulatory agencies worldwide.
• Provides expertise and guidance in interpreting recall and AER regulations, agency guidelines, and internal policies to ensure compliance.
• Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs/MIRs).
  
  

Job Responsibilities - 20%

• Prepares deliverables for, and participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.

Requirements:

• Bachelor's Degree in Business, Sciences, Engineering or related field required
• Master's Degree in Sciences, Engineering or related field preferred
• 5 years of experience in the Medical Device/Pharmaceutical Industry, preferably with IVDs or equivalent combination of education and experience to perform at this level.
• Demonstrated proficiency with domestic and international regulations required.
• Working knowledge of Medical Device Reporting (MDR), Medical Device Vigilance (MDV) Field Actions (Safety Board).
• Working knowledge of FDA regulations, ISO13485, ISO14971, In Vitro Diagnostic Regulations (IVDR), and Medical Device Directives (MDD) and Medical Device Directive (MDR).
• Ability to understand and explain regulatory compliance issues and comply with constantly changing regulatory requirements, specifically regarding.
• Thorough understanding of relevant ISO, CAP/CLIA, GCP, and US FDA regulations and guidelines.
• Results and goal oriented.
• High degree of initiative with the ability to work independently.
• Strong verbal, written and interpersonal skills.
• Ability to prepare and present information to groups.
• Ability to comprehend principles of engineering, physiology and medical device use. Experience with Microsoft based applications and general knowledge of PC functions necessary.
• An equivalent combination of education and experience may be accepted upon management and HR review.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .