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 and/or medical device industry.
• A minimum of 10 years directly communicating with and managing correspondence to worldwide Regulatory agencies.
• 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.
• Fluent in English language and specific skills such as computer skills, mathematical skills are required.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones.
• International travel up to 10% of the time should be expected.

Preferred:

• Experience developing and managing communications to regulatory agencies.
• Experience working with, presenting to and communicating with leadership.
• Experience in supporting sites/organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
• Experience writing, reviewing, and providing feedback on requests for additional information responses.
• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan)/company locations.
• Experience in both audit front and back rooms holding multiple positions.
• Site MDR/Regulatory Body Contact.
• Having prior FDA experience would be a plus for this position.
• Program management experience managing multiple programs and projects to meet deadlines.
• 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.