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Associate Territory Manager, International Regulatory Affairs

Associate Territory Manager, International Regulatory Affairs

Working Location: MASSACHUSETTS, WESTBOROUGH

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

This position supports international regulatory affairs activities including but not limited to: assist in providing international regulatory expertise to new product development and sustaining engineering team's preparation and submission of regulatory documentation for product registration/licensing in selected global markets.

Job Duties

  • Assist in the preparation of global registration dossiers to obtain product registrations in Olympus regional markets worldwide.
  • May be directed to support specific regions or key markets depending on work plans.
  • Support team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations.
  • Obtain Certificates of Export from FDA or other applicable export notifications as needed.
  • Support maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current pending and future approvals and renewals.
  • Provide progress of work-plans and the status of key project deliverables.
  • Support liaison with Olympus S-BCs and local distributors to coordinate develop and maintain international submissions.
  • Assist with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required.
  • Provide assistance in keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to company products and processes.
  • Provide assistance in advising regulatory management of changes and as appropriate aid the communication of regulatory initiatives or changes to company members.
  • As needed assist in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes Facilitate compliance activities related to global regulations and international standards.
  • Assist Director Intl RA and Executive Director RA during inspections by International Regulatory Agencies.
  • Partner with development coordination preparation and maintenance of Core International medical device submissions such as EU design dossiers & technical files and Canadian submissions.
  • Perform other essential related duties as required.


Job Requirements

REQUIRED QUALIFICATIONS:

  • Bachelor's degree is required, preferably in engineering or life sciences.
  • Regulatory affairs experience in the Medical Device industry is mandatory. Minimum of 3 years with Bachelor's degree or 1 year with MS preferred.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.

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.

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