Sr. Auditor, Global Regulatory Compliance (Remote) Job

Company Name: Boston Scientific

Location: Marlborough, MA, US - 01752

Job Duration: 2021-09-12 to 2021-10-12

Overview

Location: Remote- US Field based

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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.

 

About the role:
We are looking for a detail-oriented auditor to join our global regulatory compliance team.  In this role, you will be asked to perform detailed quality system and clinical audits of policies / practices / procedures at a global / division / site level to ensure compliance with FDA, ISO, MDD, MDR and other relevant standards and regulations.  You will be expected to partner with individuals at all levels of the organization to ensure consensus to your findings.  You will also participate on global process improvement teams to support Boston Scientific’s Best 4 Culture.  
 
Key responsibilities include:

  • Responsible for conducting and confirming follow-up actions on Global / Divisional / Site compliance audits.
  • Plan and conduct scheduled risk-based audits to assess compliance with applicable regulatory requirements, including (but not limited to) FDA (GMP/GCP), ISO, MDD, and MDR. This includes audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
  • Participate in planning, coordination, and implementation of corporate and site audit policies. To include review of updated GMP/QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate.
  • Review, understand, and implement changes related to ISO/GMP changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, training programs, other documents as required.
  • Participation with Corporate and divisional QA on policy/procedure/ guideline development. Includes generation, review, and implementation of these documents.
  • Perform post diligence quality system assessments of acquired business units.
  • Provide compliance oversight within business processes as determined necessary.
  • Assist in external regulatory (FDA / ISO / etc.) inspections.
  • Support the Boston Scientific Best 4 initiative.
  • Other duties as assigned.

 
Minimum requirements:

  • Bachelor’s degree in Life Science or other STEM field, or appropriate work experience in medical device auditing.
  • 4+ years of medical device auditing experience in the medical device, pharmaceutical, or comparable environment
  • Must be able to work independently, lead and / or participate as part of an audit team.
  • Must be able to travel (domestically and internationally) up to 25% to other BSC facilities for auditing and or/meetings and conferences.
  • Excellent verbal / written communication, interpersonal, and organizational skills; attention to detail, must be able to multi-task, assimilate, and analyze information quickly
  • Ability to work on a global virtual team
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Preferred qualifications:

  • Master’s degree in Life Science or other STEM field.
  • Experience in Clinical Operations or Clinical Auditing (GCP)
     

 

Requisition ID: 486460

 

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.