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Principal Clinical Quality Assurance Specialist (Peripheral Interventions)

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote Global
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s): Ireland-Galway

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 Peripheral Interventions (PI) Division is leading in minimally invasive therapies for arterial disease, venous disease and cancer. We are seeking a Principal Clinical Quality Assurance Specialist to join us in advancing science for life.

 

This is a fully remote position and may sit in the United States or Ireland.

 

Your responsibilities will include:

 

Clinical Compliance: Hands on partnership with Clinical for inspection readiness

  • Participate on clinical project teams to always foster and inspire clinical teams towards a state of inspection readiness
  • Provides support and response to compliance and regulation questions including quality review of clinical study documents
  • Supports Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections
  • Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs

 

Independent Auditing:

  • Plans, schedules, and conducts internal/external clinical quality audits and vendor assessments to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures
  • Documents and communicates audit observations; evaluates impact and makes recommendations for corrective actions. Evaluates responses to audit findings and ensures that appropriate corrective actions are completed
  • Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes

 

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

  • Support Clinical and QS team during External Regulatory/Notified Body audits
  • Supports the CAPA program, assessing internal noncompliance recommending initiation of NCEPs, Clinical CAPA team member working cooperatively with NCEP/CAPA owners providing quality input
  • Participates on clinical process improvement projects and initiatives
  • Supports departmental, divisional, and corporate quality goals and priorities

 

Acquisition integration:

  • Support Clinical Quality lead on clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements
  • Participates on clinical process improvement projects and initiatives
  • Supports departmental, divisional, and corporate quality goals and priorities

 

What we're looking for in you:
 

Minimum Qualifications:

  • Minimum of a bachelor’s degree
  • Minimum of 8 years’ experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines
  • Demonstrated experience in clinical Quality Assurance and/or compliance experience
  • Ability to travel domestically and internationally up to 30%

 

Preferred Qualifications:

  • RAQP-GCP/ SoCRA or ACRP certification or equivalent
  • EU CA experience 
  • 5 or more years of direct clinical quality (GCP) auditing experience
  • Demonstrated experience communicating with all levels of the organization

RSRBSC

EMV2

 

Requisition ID: 531538

 

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 

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.

 

RSRBSC

 

RSRBSC


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