Job Description

This position leads cross-functional team to investigate and develop responses to Quality/Regulatory compliance communications. Authors, leads and manages all Quality/Regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the business strategy of the company are met. Guides and coaches/mentors cross-functional teams focusing on communication with regulatory agencies regarding compliance issues.

Leads and manages the development of all global regulatory communication processes to include responses external audits, FCAs and additional information requests from regulatory agencies. Responsible for authoring, leading, managing, reviewing and coordinating compliance response communications working cross functionally with Market Quality, Marketing, Operations/Ops Quality, Regulatory, Risk and R&D in fulfilling additional request for information with worldwide regulatory agencies (i.e., worldwide requests for additional information, audit responses, etc.).

Can serve as a backup to the Global Director Quality Compliance: External Regulatory Communications. Review and provide guidance CAPAs that are linked any external responses, making sure they are on track to the committed due dates. Authors, leads the and manages initial draft response with cross functional subject matter experts to meet deadlines. Holds regular cross functional meetings to ensure commitments and deadlines are met.

This position is a technical subject matter expert in worldwide regulatory communications having been corporate/division head of worldwide regulatory communications.

Job Duties

• Authors, leads and manages the development of global regulatory communication processes to include responses to external audits, FCAs and additional information requests from regulatory agencies.
• Guides/Coaches/trains the cross functional team focusing on communication with regulatory agencies regarding compliance issues.
• Guides/Coaches/trains SMEs against regulatory requirements and commitments/QMS to make sure responses address the findings and commitments.
• Responsible for authoring, managing, 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 additional information with worldwide regulatory agencies (i.e., requests for additional information, audit responses, etc.).
• Authors, leads and manages cross functional teams on investigating, assessing and authoring responses.
• Tracks, trends, and analyses data from requests and responses to external audits, FCAs and additional information requests from regulatory agencies including audit findings, 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, audit findings and regulatory additional information requests.
• Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.
• 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, engineering discipline, or equivalent years of relevant work experience required.
• A minimum of 20 years of related professional experience in the medical device industry.
• A minimum of 15 years directly communicating with and managing correspondence to worldwide Regulatory agencies.
• Experience developing and managing communications to regulatory agencies.
• Experience working with, presenting to and communicating with executive leadership.
• 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.
• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones.
• Fluent in English language and specific skills such as computer skills, mathematical skills are required.
• International travel up to 10% of the time should be expected.

Preferred:

• Experience as both audit front and back room lead and strategist.
• Technical subject matter expert in worldwide regulatory communications having been corporate/division head of worldwide regulatory communications.
• Having prior FDA experience would be a plus for this position.
• Having prior FDA experience leading the front room and back room would be a plus.
• Program management experience managing multiple programs and projects to meet deadlines.
• Skills:
• Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (Market Quality, Marketing, Manufacturing, Quality, Regulatory, Risk, R&D, Supply Chain, etc.).
• Proven leadership, teamwork, collaboration and influencing skills.
• Ability to work effectively and with agility in a fast paced and dynamic environment.
• Working knowledge of problem-solving skills good statistical and analytical skills.
• Excellent organizational and time management skills.
• Strong knowledge in regulatory requirements and Quality Management System.
• Strong written and verbal communication skills.
• Proficient in the use of Information Technology.