Senior Specialist Global Regulatory Affairs Operations

Req ID: 9062

Working Location: 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.

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

The Senior Specialist, Regulatory Affairs Operations – Regulatory Intelligence is responsible for providing regulatory intelligence support globally, in relation to the Olympus portfolio and the regulatory landscape (e.g., international and domestic standards & regulations). The Senior Specialist will act as a point of contact in monitoring standards and the regulatory landscape, disseminating regulatory intelligence impact assessments to cross functional stakeholders, and facilitating the activities described by a global regulatory intelligence process.

Job Duties

The Senior Specialist, Regulatory Affairs Operations – Regulatory Intelligence will perform the following:

Perform regular monitoring of the regulatory environment, to identify potential Regulatory Intelligence which may impact Olympus’ product portfolio.
Aggregate identified Regulatory Intelligence and perform quality checks to confirm that information is accurate.
Provide cross functional stakeholders (internal and external to Regulatory Affairs) with impact assessment information to partner with teams to support implementation of regulatory intelligence and regulatory compliance of Olympus’ portfolio and operations.
Monitor the implementation status of new regulatory requirements based on Regulatory Intelligence.
Drive quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus.
Provide guidance to cross-functional stakeholders on the regulatory intelligence global process.
Monitor and maintain global process tracking information to inform KPIs and ensure efficiency and quality of tasks.

Job Qualifications

Required:

Bachelor’s degree in Engineering, Non-Medical or Science (or similar) is required. Master’s degree preferred.
Experience in medical device Regulatory Affairs, Quality Assurance, or Research & Development (minimum 5 years), ideally in a matrix organization.
Experience supporting significant parts of the end-to-end product lifecycle management activities.
Has a broad understanding of the global medical device regulatory landscape, regulatory submissions (e.g., 510(k), CE Mark etc), and international standards utilized to demonstrate conformance with regulatory requirements.
Experience operating within regulated environments, QMS processes and systems.
Experience working globally with understanding of global process flows and teaming.
Strong IT skills – experience utilizing a relevant regulatory system (desirable, e.g., RIM / PLM), QMS systems (essential) and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams)
Travel may be required 10-20% of the time (both domestic and international). Global regulatory intelligence activities may require availability outside of normal work hours.

Preferred:

Qualified candidates will ideally have regulatory project management support experience, in particular covering regulatory intelligence, project management, submissions, and publications.
Leadership and strong interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality etc)
Strong written, verbal, and presentation communication skills.

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, 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
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 $83,187.00 - $112,302.00 / 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 OCAAccommodations@olympus.com. 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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Job Segment: QA, Quality Assurance, PLM, R&D Engineer, Project Manager, Technology, Quality, Management, Engineering

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