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Boston Scientific (BSC) needs to ensure that clinical research activities conform to federal and international regulations and BSC procedures through detailed clinical process and vendor audits across all clinical divisions globally.

Requirements

• Auditing experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines or equivalent relevant experience
• Strong experience with ISO 13485
• Working knowledge of US and International regulations and standards applicable to BSC
• Working knowledge of ISO 14155, GCP, Real World Data Vendors and Digital Health Technologies
• Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.

Responsibilities

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical divisions.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits along with various SMEs (e.g. software quality) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute to appropriate stakeholders.
• Own and manage related clinical vendor non-conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g. ISO, FDA medical device regs, GCP, etc.).
• Support the preparation, coordination, and participation of regulatory agency inspections of BSC offices for clinical.

Other

• Bachelor’s degree in Science, Health or relevant field of expertise
• Minimum of 10 years of work experience in the medical device/pharmaceutical/similar regulated industry
• High degree of integrity, professionalism, and ability to establish credibility
• Ability to travel
• Experience working cross functionally with multiple stakeholders