Location: Westborough,MA, USA
Working Location: MASSACHUSETTS, WESTBOROUGH; PENNSYLVANIA, CENTER VALLEY
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.
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.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
* Competitive salaries, annual bonus and 401(k)* with company match
* Comprehensive medical, dental, vision coverage effective on start date
* 24/7 Employee Assistance Program
* Free live and on-demand Wellbeing Programs
* Generous Paid Vacation and Sick Time
* Paid Parental Leave and Adoption Assistance*
* 12 Paid Holidays
* On-Site Child Daycare, Caf, Fitness Center
Connected Culture you can embrace:
* Work-life integrated culture that supports an employee centric mindset
* Offers onsite, hybrid and field work environments
* Paid volunteering and charitable donation/match programs
* Diversity Equity & Inclusion Initiatives including Employee Resource Groups
* Dedicated Training Resources and Learning & Development Programs
* Paid Educational Assistance
* US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives.
The anticipated base pay range for this full-time position working at this location is $114,213.00 - $159,898.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 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 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
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.
Applicants with Disabilities:
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at ...@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-###-####).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development