Principal, Global Quality Compliance: External Regulatory Communication - Remote

Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

This position leads cross-functional team to investigate and develop responses to additional information requests from regulatory agencies worldwide. The position will be responsible for reviewing and authoring all worldwide additional information request responses prior to submission to corporate leadership and/or regulatory agencies.

This position will ensure adequate tracking, monitoring and trending of all worldwide additional information and will also provide routine progress updates and escalation of potential compliance issues to functional and site leadership respectively. Will provide guidance on investigation and facilitate timely corrective/preventive actions on issues identified in regulatory body requests. The position will provide guidance, training, and coaching to team on quality compliance matters including on communication on responses. The individual will have experience as the site MDR/Regulatory Body contact.

Job Duties

• Authors and manages the development of global additional information regulatory communication processes to include responses to information requests from regulatory agencies. 
• Guides/Coaches the cross functional team focusing on communication with regulatory agencies regarding compliance issues. 
• Guides/Coaches SMEs against regulatory requirements/QMS to make sure responses address the request.
• Responsible for reviewing and coordinating compliance response communications working cross functionally with Market Quality, Marketing, Operations/Ops Quality, Regulatory, Risk and R&D in fulfilling request for information with worldwide regulatory agencies (i.e., requests for additional information, etc.).
• Authors and leads cross functional teams on investigating, assessing and authoring responses.
• Tracks, trends, and analyses data from requests and responses to additional information requests from regulatory agencies including corrective actions, root cause and remediations to provide inputs for quality system and processes enhancement or improvements.
• Ensures commitments and deadlines for external responses are met.
• Makes recommendations based on compliance and patient risk. Identifies issues that require prompt notification and presents/communicates to leadership in a clear and concise manner.
• Escalates potential safety issues for risk assessment or health hazard assessment.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Develops new approaches to solve problems identified as part of cross functional team.
• Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.
• Site MDR/Regulatory Body Contact.
• Participates in the review of CAPAs and CAPA process as required as an assignee or project team member.

Job Qualifications

Required:

• Bachelor’s degree in a science or engineering discipline required.
• A minimum of 12 years of experience in healthcare, pharmaceutical an