Senior Regulatory Affairs Specialist II, Digital Health

Req ID: 10049

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; 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: https://www.olympusamerica.com/careers.

Job Description

The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports regulatory activities across the Olympus Digital Unit (DU). The Digital Unit is a new, global, high-growth area at Olympus focused on how digital technologies can help transform current and future products.

This position contributes to ensuring compliance of Olympus’ digital health products and solutions with applicable regulatory requirements worldwide. As part of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance, prepare and maintain documentation, and support submissions related to digital health technologies, including software, and connected systems. Working closely with the DU’s development teams, the RA Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving regulations, and collaborating cross-functionally with product development, quality assurance, privacy, and cybersecurity teams to ensure compliance throughout the product lifecycle.

Job Duties

Participate in product teams developing new digital health technologies and connected software systems. As needed provide input to define global regulatory strategy requirements.
Participate in teams for sustaining products to provide input on global regulatory requirements.
Support regulatory submissions, filings, and responses to regulatory or auditor inquiries as directed.
Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration on for other international markets such as Japan, Middle East and Africa, Australia and Latin America.
Assist in ensuring that Olympus digital health solutions comply with applicable global regulations and standards (e.g., IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, cybersecurity and consumer protection laws).
Monitor evolving regulatory frameworks related to digital health, AI, and data privacy, summarizing key updates and communicating their impact to relevant stakeholders.
Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information.
Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management.
As needed assist in the development and maintenance of regulatory standard operating procedures (SOPs), work instructions, and templates related to digital health compliance.
Assist with training activities to promote awareness of regulatory requirements and best practices among Digital Unit teams.

Job Qualifications

Required:

BS or comparable in engineering or life sciences required.
Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years with master’s degree.
Previous experience working in a global environment; demonstrated sensitivity to cultural differences.
Familiarity with digital health regulatory frameworks for medical devices and frameworks outside of traditional medical devices (IEC 62304, IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act).
Experience preparing or maintaining regulatory documentation and supporting submissions or audits.
Understanding of global digital health regulatory landscapes and voluntary compliance schemes.
Effective communicator with strong organizational and documentation skills.
Ability to work independently while contributing to cross-functional project teams.
Passion to challenge the status quo and find new strategic directions – embraces change.
Comfortable pushing back on multiple parties at the same time.
Excellent writing and verbal skills.
On occasion, but not more than 10 %

Preferred:

MS in engineering or life sciences preferred.
Experience with medical device software, including software in a medical device (SiMD) and software as a medical device (SaMD), preferred.
Knowledge of regulatory submissions such as 510(k), De Novo, or CE marking for software-based medical devices is advantageous.

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
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 benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $92,499.00 - $129,498.00 / 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.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact 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).

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)

Nearest Major Market: Worcester
Job Segment: QA, Quality Assurance, PLM, Engineer, Technology, Quality, Management, Engineering

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