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Analyst, Sr. Regulatory Affairs - OMS

Req ID:  822

Working Location: MEXICO, MEXICO CITY 

 

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.

Job Description

This position will act as the subject matter expert (SME) for Olympus product registrations in Mexico. This function prepares complete registration dossiers for submission (included but not limited to New Registrations, Modifications, Renewals, Import Licences/Permits, etc) to the Mexican regulatory agency (COFEPRIS). As part of this function, this individual may also act as the Sanitary responsible or Technical Vigilance representative for OMS. The incumbent will be responsible to assure accurate product registration execution.  This function supports the procurement, organization, logging and filing of regulatory documentation related to product registrations and vigilance activities in Mexico.

Job Duties

Mainly: 

 

  1. Request, collect and review technical/legal documentation from OLA and/or Manufacturing Business Centers assuring its adequacy to the registration requirements in Mexico.
  2. Maintain the product registration and documentation databases (Ie: Endowise) and regulatory submission files.
  3. Prepare reports to be shared with different areas in the organization to communicate product registration status and milestones associated with registration activities and other projects. 
  4. Interface with Local Regulatory Agencies and Customs to understand changes to existing laws and to facilitate the identification and resolution of technical and regulatory issues as they apply to registration and importation of medical devices. Keeping up to date with changes in regulatory legislation and guidelines.
  5. Review document change requests for compliance with regulatory requirements and government submissions.
Job Requirements
  • Bachelor’s Degree in science, biology, chemistry or a related field.
  • Minimum 3 years direct experience in regulatory affairs and quality assurance at a medical devices or pharmaceutical company
  • Practical (hands-on) experience in a regulatory environment for medical devices preparing submissions.

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.

The Olympus Latin America Division (LAD) encompasses three subsidiaries within Olympus Corporation of the Americas including Olympus Latin America, Olympus America de México, and Olympus Optical do Brazil. Throughout their respective regions, each subsidiary manages Olympus’ operations, distributor partnerships, and workforces in roles such as sales, marketing and support functions. For more information, visit olympuslatinoamerica.com and truetolife.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.

Posting Notes: || Mexico (MX) || Distrito Federal (MX-DIF) || Mexico, D.F. || 


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