Job Description

Leads and directs regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and the business strategy of the company. Manages the Global QA&RA Compliance development and implementation of the Global external audit processes, programs, and activities with a focus on communication with regulatory agencies regarding compliance issues. Provides onsite leadership support during external regulatory audits as required. Directs the development of global regulatory communication processes to include responses to external audits as well as routine information requests from regulatory agencies. Responsible for all compliance response communications (VAI, OAI etc.) with regulatory agencies as well as fulfilling routine requests for information with regulatory agencies such as RFAIs. Leads the development and maintenance of the Olympus Site Compliance Risk Assessment. Can serve as a backup to the Director Global QA&RA aCompliance, External Audit.

Job Duties

• Manages the development and implementation of the Global external audit communication processes, programs, and activities.
• Directs the development of external audit responses, manages the completion and delivery of responses to the US FDA, Notified Bodies, and other authorities as required. Manages the development, implementation and maintenance of a Global audit response process. · Responsible for the completion and submission of regulatory compliance requests for information to the US FDA, Notified Bodies, and other authorities.
• Manages the development and delivers Global QA&RA Compliance organizational communications.
• Directs the development and implementation of new monitoring and reporting tools that measure progress of external audit schedules and audit outcomes. Identifies, accesses, and analyzes data that have impact on the company’s compliance with overall quality systems. Tracks, trends, and analyzes external audit findings, corrective actions, and remediations. Make recommendations based on areas of highest compliance risk.
• Directs the development and maintenance of the Olympus Site Compliance Risk Assessment.
• Provides leadership to the Global External Audit Communities of Practice.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advise management on potential improvements or enhancement to quality systems and processes in the company.
• Develops new approaches to solve problems identified as part of the team. Directs the implementation of Global QA&RA Compliance initiatives and programs throughout the Global organization.
• Participates in the CAPA process as required as an assignee or project team member

Job Qualifications

Required:

• Bachelor’s degree in engineering discipline or equivalent.
• Minimum of 10 years related experience in the medical device industry. Experience with Regulatory Agency (FDA) as Compliance Officer is favorable.
• Minimum of 5 years people management experience.
• Very strong risk/auditor skills – critical to evaluate remediation of issues and management’s action plans.
• Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
• Direct experience in US FDA, Notified Body, and other International Regulatory Agency Audits. Experience with supporting sites during regulatory audits is required.
• Experience writing, reviewing, and providing feedback on audit responses to regulatory authorities specifically to FDA, is required.
• Experience with managing and submitting regulatory agency requests for compliance information is required.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 40 % of the time should be expected.
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Preferred:

• Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…).
• Ability to work effectively in a fast paced and dynamic environment.
• Working knowledge of problem-solving skills good statistical and analytical skills.
• Strong written and verbal communication skills.
• Proficient in the use of Information Technology.

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