Principal Clinical Quality Assurance Specialist

Additional Locations: Belgium-Diegem

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Our Rhythm Management Clinical Quality Assurance team rigorously pursues adherence to good clinical practice within some of the most challenging clinical device trials conducted in pursuit of transforming lives with groundbreaking technologies that address irregular heart rhythms, heart failure and sudden cardiac arrest.

We are seeking an engaging and qualified Principal Clinical Quality Assurance Specialist who is aligned with our core values that define Boston Scientific culture and empower our employees: Caring - Meaningful innovation - High performance - Global collaboration - Diversity - Winning spirit.  Because a career with Boston Scientific is more than just a job. It’s personal. We’re committed to solving some of healthcare’s toughest problems – united by a deep caring for human life. If you’re a natural problem-solver with the imagination, courage, and spirit to make a meaningful difference in clinical quality, there’s no better place to build your career.

This is a high visibility hybrid position supporting a global Clinical team conducting investigational electrophysiology and cardiac rhythm management/diagnostic medical device studies at global sites.  Qualified OUS candidates are encouraged to apply.

Your responsibilities will include:

Clinical Compliance: Hands-on partnership with Clinical for clinical quality consultation and inspection readiness:

• Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
• Provides support and response to clinical quality, compliance and regulation questions including quality review of clinical study documents and related functional study plans
• Owns and/or supports management of internal clinical, external investigator site and clinical supplier nonconforming event management and CAPAs
• Supports Clinical Inspection Readiness program to include inspection readiness training and coordination, and participation in internal Mock BIMO inspections as well as external audits/inspections
• Communicates with internal stakeholders regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs

Independent Auditing:

• Creates risk-based study audit plans; plans, schedules, conducts, provides internal oral debriefs and writes formal audit reports to internal stakeholders and leadership  for internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational pre-market, post-market and post approval  clinical studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
• Documents evidence and provide rational and authoritative citations for audit observations of nonconformance;  communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed
• Keeps abreast of and interprets current worldwide regulatory requirements and good clinical practice standards; advises various stakeholders regarding possible ramifications of regulatory changes 

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements:

• Demonstrate an unwavering commitment to patient safety and clinical quality by adhering to the Quality Policy and all documented processes and procedures, and maintaining a patient centric quality focus
• Supports Clinical and QS team during External Regulatory/Notified Body audits/inspections
• Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure
• Participates in clinical process improvement projects and initiatives

• Provides reviews and comments in relevant BSC procedure revisions

• Supports departmental, divisional, and corporate quality goals and priorities 

Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System.

Acquisition integration:

Represents Clinical Quality on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data.

What we are looking for in you: 

Minimum Qualifications:

• Minimum of a bachelor’s degree in Science, Health, Engineering, or a related field with minimum of 8 years’ experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 10years of relevant clinical research experience
• Demonstrated clinical research audit, compliance and related writing experience with one or more of the following: clinical trial primary research coordinator or monitor, GCP auditor, CAPA leader, research compliance auditor, clinical research SOP author, or equally relevant role

• Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance

• Working knowledge of regulations, standards, paper and electronic Good Documentation Practices, and privacy/security obligations relevant to conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155 and/or ICH E6), HIPAA and GDPR
• Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals

• Demonstrated experience and critical thinking with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills and strong presentation skills – Must be proficient in English
• Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
• Proficiency in MS Office apps WORD, Outlook, TEAMS, Excel, PowerPoint, SharePoint
• Ability to travel domestically and internationally up to 30%

Preferred Qualifications:

• RAQP-GCP/ SoCRA, CCRP, CHRC, or ACRP certification or equivalent
• Experience with maintaining compliance with medical device manufacturer quality system or other clinical quality system requirements
• EU CA, Health Canada, PMDA, CFDA experience regarding clinical research, submissions and inspections
• 5 or more years of direct clinical quality (GCP) auditing experience
• Knowledge of EU MDR pertaining to clinical investigations of medical devices
• Non-English language(s) proficiency for reliable verbal and written audit related reviews and communication with EU investigational sites (e.g., France, Germany, Italy, Spain)
• Demonstrated experience communicating with all levels of a complex organization

Requisition ID: 621953

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!