Olympus Corporation of the Americas Regulatory Affairs Manager, International - Remote in Westborough, Massachusetts
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Field
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.
The Regulatory Aﬀairs (RA) Manager International is responsible for coordinating regulatory activities across the Therapeutic Solutions Division (TSD) portfolio, for all offerings designed in the US, focusing on the international markets. The position requires extensive interaction and strong liaison with relevant stakeholders, externally at OEM suppliers and internally across all functions, including supply chain management and business units, and Olympus regional teams for the maintenance of TSD devices to the respective markets.
Interface with global regulatory counterparts to ensure compliant submissions for products.
Liaise with product RA counterparts to support new product development.
Maintain licenses, including renewals and updates for changes, for current product portfolio.
Assess impact of changes to applicable laws and regulations and identify impact to the business and in collaboration with other stakeholders, develop strategies to address.
Responsible for managing the maintenance of international product dossiers by reviewing and monitoring changes to and identifying potential risks to existing and future business.
Support responses to regulatory body inquiries and support audits by regulatory bodies.
Oversee programs that assure compliance with all regulatory requirements that apply to medical device manufacturers.
Responsible for establishing and maintaining effective working relationships to partner with relevant internal and external stakeholders, including Olympus regional teams; OEM suppliers, business units and supply chain management, to coordinate and maintain regulatory licenses.
Knowledgeable in the applicable global regulations and quality systems regulations. Represent RA in providing guidance and expertise on global submissions within the RA team and internally across all functions and all levels of the organization, and externally to OEM suppliers.
Develop and maintain documented regulatory procedures as required to assure consistent and compliant regulatory activities.
Provide support for cross functional initiatives including manufacturing engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance.
BS/BA required, preferably in engineering or life sciences or advanced degree and/or other relative experience.
Minimum of 8 years’ experience in Regulatory Aﬀairs in Medical Device Industry. Supervisory experience is required.
Demonstrated experience with standards, guidance documents and best practices related to medical devices.
Highly analytical, attentive to detail, organized, ability to execute, flexible and adaptable, collaborative, ethical, strong communication skills (verbal, written, etc.), and ability to work across multiple departments.
Extensive knowledge of medical device regulations.
Experience with a medical device quality system.
Good recordkeeping and attention to detail
Organizational skills, detail oriented, trustworthy
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
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**
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.olympusamerica.com/careers/benefits-perks .
The anticipated base pay range for this full-time position working at this location is $100,022.00 - $140,032.00 / 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.
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 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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
Olympus Corporation of the Americas
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