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Principal Compliance Analyst Job

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Date: Jan 7, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

 

 

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

 

 

 

About This Role:

The Principal Compliance Analyst position reports directly to the Senior Manager, Quality Systems, Arden Hills, Minnesota.

 

The suitability, adequacy, and effectiveness of Boston Scientific’s Quality System as implemented throughout the Arden Hills, Minnesota site is audited frequently by various external regulatory compliance authorities (e.g., FDA, BSI, DEKRA, TUV-R, and other geography-specific agencies from around the world). The Principal Compliance Analyst position leads and coordinates all efforts regarding external audit preparation, execution, and closure activities for each audit. The primary responsibilities of the role include interfacing directly with Arden Hills Quality System Process and Sub-Process owners, Subject Matter Experts, and Management and Global Quality Systems personnel, as needed, to ensure functions are clear regarding scope of each audit and expectations of readiness to support all audits involving those functions. Responsibilities include logistical preparation such as developing audit support staffing plans, communicating status of audit preparation, and leading preparation meetings with SMEs. The Principal Compliance Analyst is also responsible for maintaining the site’s Quality System certificates and submitting Notifications of Change as required. This position also responds to Quality System information requests from worldwide Boston Scientific locations and may support additional activities such as Quality System integration and/or provide general support for other initiatives and projects. This role may have direct reports.

 

 

Your Responsibilities Will Include:

  • Lead Arden Hills External Audit preparation, execution, and closure activities, including leading the nonconformance responses process if necessary
  • Backroom Manager for Quality System external audits executed in Arden Hills
  • Primary Arden Hills representative on the External Audit Global Community of Practice
  • Manage and provide input into multiple Quality System certificates at both the site and corporate level
  • Identify, assess, and submit Notifications of Change to applicable Notified Bodies
  • Lead the response to Quality System information requests from other BSC sites
  • Lead information gathering and preparation activities for applicable global QS meetings and forums (e.g., audit readiness, signals review)
  • Lead and/or support quality system-related education initiatives
  • Lead and/or support Quality System Sub-Process integration activities related to external audit readiness
  • May educate functional areas on quality system requirements
  • Work with Quality and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions as appropriate
  • Promote a work environment that supports the global Quality Policy, global Quality System, Continuous Improvement and Winning Culture at Arden Hills
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities
  • As applicable and assigned, may have supervisory responsibilities for direct reports who would support external audit program, QS certificate management, QS information requests, and other aspects of Quality System

 

 

What We’re Looking For In You:

Minimum Qualifications

  • Bachelor’s degree and 7+ years relevant experience, preferably in medical device industry
  • Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management, including but not limited to:  21 CFR Part 820, ISO 13485, EU MDR 2017/745, AIMDD, MDD, MHLW Ordinance 169, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC 16/2013, 21 CFR Part 4, as applicable to site
  • Comprehensive working knowledge, interpretation and application of MDSAP program
  • Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
  • Excellent verbal / written communication, interpersonal, project management, and organizational skills
  • Ability to lead others to achieve common goals and objectives
  • Ability to multi-task and analyze information quickly
  • Ability to demonstrate equanimity, effectiveness, and leadership in challenging situations
  • Ability to communicate with all levels of the organization
  • Must be proactive, work independently, and be a contributing member of a highly visible team
  • Ability to work effectively from home
  • Ability to understand and support requirements and processes put in place due to COVID-19

Preferred Qualifications

  • Experience managing, coordinating, or supporting external audits of medical device quality systems

 

 

 

 

 

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 473263

 


Nearest Major Market: Minneapolis

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