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Regulatory Affairs Specialist I

Olympus Medical Systems

Olympus Medical Systems

Legal
Westborough, MA, USA
Posted on Saturday, June 22, 2024

Working Location: NATIONWIDE

Workplace Flexibility: Hybrid

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.

Job Description

The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technical documentation and conduct other elements of sustaining Regulatory Affairs including maintaining “state of the art”. In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations.

Job Duties

  • Review, assess and maintain EU Technical Files, GSPR Checklists, Declarations of Conformity and supporting documents so that they are compliant with current regulations and company standards.
  • Participate in “state of the art” projects ensuring that new and revised standards are implemented on Olympus products.
  • Participate in sustaining projects that relate to the ongoing maintenance of regulatory compliance for our products.
  • Provide regulatory support on the creation and maintenance of clinical evaluations and supporting documents.
  • Assign, review and maintain the EU Basic Universal Device Identifiers (BUDI).
  • Provide regulatory support on the creation and maintenance of master product data.
  • Provide support in the maintenance and use of the Regulatory Information Management System (RIMS).
  • Provide regulatory support or approvals to Quality System and Regulatory workflows (change orders, NCRs, audit findings, CAPAs).
  • Support the regulatory department on various other projects, initiatives and tasks.

Job Qualifications

Required:

  • Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3 years with BS/BA, or 5 years with Associates degree].
  • Must be able to meet deadlines and be detail oriented. Good planning and organization skills a must.
  • Strong knowledge of EU MDR and other supporting regulatory requirements including labelling, technical documentation and standards.'

Preferred:

  • BA/BS in Life Sciences preferred. Documented continuing education in regulatory affairs or RAC Certification is a plus.
  • Ability to work in small team environment, but also self-starter with ability to work independently.
  • Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
  • Strong critical thinking and problem-solving skills.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and private pension plan
  • Comprehensive Medical and Dental coverage effective on start date
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • Educational Assistance
  • Volunteering program
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • Meal Vouchers and food vouchers
  • Mobility Voucher
  • Total Pass

About us:

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)