Director of Global Quality and Regulatory Affairs

7 days ago

Westborough, Massachusetts, United States Olympus Corporation of the Americas Full time
Job Description

Job Summary:

Olympus Corporation of the Americas is seeking a highly experienced and skilled Director of Global Quality and Regulatory Affairs to lead our quality and regulatory efforts. This role will be responsible for ensuring compliance with regulatory requirements and developing strategies to improve quality and regulatory performance.

Key Responsibilities:

  • Lead Cross-Functional Teams: Direct and manage cross-functional teams to document responses to requests for additional information from regulators, ensuring communications adhere to the Global Quality System and applicable regulatory requirements.
  • Review and Approve Communications: Responsible for reviewing complaint handling requests for additional information and other post-market responses prior to submission to regulators.
  • Develop Global Processes: Develop a global post-market regulator communication process, including tracking and trending of responses to regulators.
  • Provide Guidance and Training: Provide guidance, training, and coaching to team members on quality compliance matters, including communication with regulatory agencies regarding post-market issues.
  • Manage Emerging Issues: Gather, maintain, and distribute Emerging Issues communications to internal stakeholders.
  • Identify and Escalate Issues: Identify issues that require escalation to leadership and potential issues for consideration for risk assessment or Health Hazard Assessment.

Job Duties:

  • Develop and Implement Processes: Develop and implement the global regulatory requests for additional information communication process and activities.
  • Manage Regulatory Requests: Responsible for the completion of regulator requests for additional information to the US FDA and other Regulatory Authorities as applicable.
  • Lead Investigations and Responses: Lead cross-functional teams on investigating, assessing, and authoring responses.
  • Track and Analyze Data: Track, trend, and analyze requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements.
  • Manage Emerging Issues Reports: Gather, collate, and maintain Emerging Issues reports; distribute and present to internal stakeholders.
  • Identify and Communicate Issues: Identify issues that require prompt notification and present/communicate to Olympus senior leadership in a clear and concise manner.
  • Escalate Potential Safety Issues: Escalate potential safety issues for risk assessment or health hazard assessment.
  • Manage Global Hot Topic Communications: Manage the development of Global Hot Topic communications.
  • Collaborate with Customer Quality: Work together with the Customer Quality organization to identify, access, and analyze data that have an impact on the company's compliance with overall quality systems.
  • Apply Problem-Solving Methodologies: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Advise Management: Advise management on potential improvements or enhancements to quality systems and processes in the company.
  • Develop New Approaches: Develop new approaches to solve problems identified as part of the team.
  • Participate in Global Initiatives: Participate in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.
  • Participate in CAPA Process: Participate in the CAPA process as required as an assignee or project team member.

Qualifications:

  • Education: Bachelor's degree in a science, engineering discipline, or equivalent.
  • Experience: A minimum of 15 years of related professional experience in the medical device industry.
  • Management Experience: A minimum of 5 years managing direct or indirect teams in the medical device environment.
  • Regulatory Experience: Experience developing and managing communications to regulatory agencies.
  • Leadership Experience: Experience working with, presenting to, and communicating with executive leadership.
  • Regulatory Knowledge: 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.
  • Audit Experience: Experience in supporting sites/organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
  • Writing and Reviewing Experience: Experience writing, reviewing, and providing feedback on requests for additional information or audit responses.
  • Global Experience: Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
  • International Travel: International travel up to 25% of the time should be expected.

Preferred Qualifications:

  • Interpersonal Skills: Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, etc.).
  • Leadership Skills: Proven leadership, teamwork, collaboration, and influencing skills.
  • Problem-Solving Skills: Ability to work effectively and with agility in a fast-paced and dynamic environment.
  • Statistical and Analytical Skills: Working knowledge of problem-solving skills, good statistical, and analytical skills.
  • Communication Skills: Strong written and verbal communication skills.
  • IT Skills: Proficient in the use of Information Technology.
  • Language Skills: Fluent in English language.

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