Principal, Global Quality Compliance: External Regulatory Communication - Remote

Olympus Corporation of the Americas; Westborough (MA); Remote; USD 90,000 - 127,000; Full time

Job summary

Join a forward-thinking company as a Principal in Global Quality Compliance, where you'll lead a dynamic team to address regulatory inquiries and enhance patient safety. This role offers an opportunity to shape global communication strategies with regulatory agencies while ensuring compliance across multiple regions. You'll engage with diverse teams, provide training, and drive improvements in quality systems. With a commitment to innovation and patient care, this position is ideal for a seasoned professional eager to make an impact in a global organization. Embrace a culture that values diversity and fosters personal and professional growth.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

24/7 Employee Assistance Program

Free Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave

On-Site Child Daycare

Fitness Center

Paid volunteering and charitable donation programs

Qualifications

• 12+ years in healthcare/pharmaceutical/medical device industry required.
• Experience managing regulatory agency communications and compliance.

Responsibilities

• Lead cross-functional teams to develop regulatory communication processes.
• Ensure compliance responses meet regulatory agency requests.

Skills

Regulatory Communication

Problem-Solving

Leadership

Interpersonal Skills

Analytical Skills

Project Management

Statistical Skills

Communication Skills

Education

Bachelor’s degree in a science or engineering discipline

Tools

Quality Management System (QMS)

Information Technology

Job description

Principal, Global Quality Compliance: External Regulatory Communication - Remote

Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE

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.

Job Description

This position leads a 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 the team on quality compliance matters including 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 ensure 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 requests 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 remediation 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 the 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.
• Experience developing and managing communications to regulatory agencies.
• Experience working with, presenting to and communicating with 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 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.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones.
• Experience in both audit front and back rooms holding multiple positions.
• Site MDR/Regulatory Body Contact.
• 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.
• Fluent in English language and specific skills such as computer skills, mathematical skills are required.
• Program management, multitask, teamwork.
• International travel up to 10% of the time should be expected.

Preferred:

• Having prior FDA experience would be a plus for this position.

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
• 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, Café, 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

The anticipated base pay range for this full-time position working at this location is $90,243.00-$126,339.00/ 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 [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)