GLOBAL DIRECTOR QUALITY COMPLIANCE: EXTERNAL REGULATORY COMMUNICATIONS

Working Location.
PENNSYLVANIA, CENTER VALLEY   Workplace Flexibility.
Hybrid Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do.
Integrity – Empathy – Agility – Unity – Long-Term View   We deliver on our purpose and our core values by staying True to Life.
Job Description Leads and directs regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the business strategy of the company.
Manages team focusing on communication with regulatory agencies regarding compliance issues.
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 reviewing and coordinating compliance response communications (VAI, OAI etc.) with regulatory agencies as well as working with Post Market Quality in fulfilling routine requests for information with regulatory agencies such as RFAIs.
Job Duties Lead a team that manages the development and implementation of the Global external audit communication processes, programs, and activities.
Responsible for the completion and submission of regulatory compliance requests for information to the US FDA, and where needed for the Notified Bodies, and other Regulatory Authorities.
Manages the development of Global QA&RA Compliance organizational communications.
Works together with the QARA Compliance team to identify, access, and analyze 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 compliance risk and present these risks to senior leadership at Olympus in a clear and concise manner.
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.
Participates in the implementation of Global QA&RA Compliance initiatives and programs throughout the Global organization, as required.
Participates in the CAPA process as required as an assignee or project team member.
Job Qualifications Required.
Bachelor’s degree in a science, engineering discipline, or equivalent A minimum of 15 years of related professional experience in the medical device industry.
A minimum of 5 years managing a team in the medical device environment.
Experience developing and managing communication to regulatory agencies.
Experience working with C-Suite executives in particular the CQO.
Requires background and familiarity with applicable regulatory requirements, including but not limited to U.
.
FDA, EU MDD/MDR, ISO , Health Canada, MHLW, ANVISA, and TGA.
Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
Experience writing, reviewing, and providing feedback on audit responses.
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.
International travel up to 20 % of the time should be expected.
Preferred.
Having prior FDA experience would be a plus for this position.
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.…).
Proven leadership, teamwork, collaboration and influencing skills.
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.
Fluent in English language  Why join Olympus? Here, people matter—our health, our happiness, and our lives.
Competitive salaries, annual bonus and 401(k)* with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center** *US Only **Limited locations   We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at https://www.
lympusamerica.
om/careers/benefits-perks.
About us.
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than employees worldwide in nearly 40 countries and regions.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than employees throughout locations in North and South America.
For more information, visit  www.
lympusamerica.
om.
Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.
We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes.
|| United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)