Boston Scientific Corporate Clinical Quality Assurance Principal Specialist 

United States, Massachusetts, Marlborough 

695602733

The Corporate Clinical Quality Assurance (CQA) Principal Specialist will help manage Corporate CQA activities in line with strategies and goals set by Quality and Clinical management. Ensures clinical research activities conform to federal and international standards and BSC processes and expectations. This role will help drive the implementation of Quality Management-approved solutions to ensure compliance through effective, efficient, and sustainable processes.Your responsibilities will include:

• Work with Quality and Clinical Stewards and senior management to support maintenance of the Product Approval – Clinical Trial quality system subprocess including process improvements, maintenance of procedures to regulatory requirements, and addressing compliance risks.
• Collaborate with Global Clinical Operations to ensure ongoing compliance of clinical research activities and operational efficiency through support of CAPAs, process improvement initiatives, and clinical systems.
• Acts as a consultant relative to the interpretation of regulations and their impact on Clinical trial processes and implementation of new QS requirements.
• Help identify key areas of regulatory risk and suggest potential resolutions as well as ways to improve compliance to regulations and BSC policies and procedures.
• Partner with divisional/regional Clinical Quality teams to gather data for management reviews and maintenance of clinical quality dashboards.
• Support analysis of Clinical metrics to identify opportunities for improvement.
• Support internal and external audits of BSC, as needed.
• Contribute as SME to the development and maintenance of BSC policies and procedures, as needed.
• Lead project activities, as needed, under the direction of Quality Management. Develop project plans outlining work plans, timelines, roles, and resources.
• Communicate status, risks, and resolutions to management on key initiatives.
• Create relationships across the business that enable sharing of knowledge, best practices, and solutions that can be leveraged across Clinical.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Minimal travel

What we’re looking for in you:
Required Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field
• Minimum of 7 years of Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs experience
• Medical device industry experience required
• Working knowledge of FDA, ISO, EU MDR, and medical device industry quality requirements governing human subject research.

Preferred Qualifications:

• Ability to work collaboratively with cross-functional and cross-divisional partners
• Strong communication skills
• Tableau experience a plus
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.