Share this Job
Apply now »

Supv., Asuntos Regulatorios y Aseguramiento de Calidad

Req ID:  5204

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 is responsible for overseeing local regulatory and quality system activities for Mexico. This function prepares final registration dossiers for submission to the Mexican regulatory agency (COFEPRIS) and acts as a liaison between Olympus Mexico (OMS) and COFEPRIS. As part of this function, this individual also acts as the Sanitary responsible representative for OMS and also as QA Management Representative and responsible for the QMS at OMS. Thus, responsible for ensuring that OMS and 3rd party vendors working on behalf of OMS comply with all applicable quality, regulatory and legal requirements in Mexico. This function is responsible for ensuring the identity and safety of the products is maintained at any facility where Olympus product is serviced, stored, or distributed in Mexico. This function supports the procurement, organization, logging and filing of regulatory documentation related to product registrations and vigilance activities in Mexico. This function will also be responsible to support regional activities/projects.

Job Duties

Acts as the Sanitary Responsible and if required as Technical Vigilance representative for Olympus America de Mexico (OMS). Is also, responsible for the QMS and is the subject matter expert for Olympus Product registrations in Mexico. Requests, collects and reviews technical/legal documentation from Manufacturing Business Centers and/or OLA assuring its adequacy to the registration requirements in Mexico. Maintains the product registrations and documentation databases (i.e.: Delphi) and regulatory submission files. Partner with cross functional teams providing regulatory guidance and support for strategic planning, design and compliance activities in regard to product registration in Mexico and/or other countries in the region, if is needed. Hold regular meetings and prepare reports to be shared with different areas in the organization to communicate project status and milestones associated with product registration activities and other projects. 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.Remain current with local and international regulations (including ISO 13485, MDSAP and Quality System Requirements) in Mexico and communicate information out to the organization. Develop training materials for internal and external personnel about RA and QA topics. Work with marketing to develop registration strategies for new product launches, renewals, and modifications to existing registrations to assure continued commercialization. 

Job Requirements

Education / Training*: Bachelor’s Degree in science, biology, chemistry or a related field compatible with the requirements for a Sanitary Responsible representative in Mexico Certificate / License / Registration ISO 13485 preferred. Knowledge of business and management principles, including performance management Solid knowledge of Mexico regulatory processes, including class II & III medical devices.Experience*: Minimum 5 years direct experience in regulatory affairs and quality assurance at a medical devices or pharmaceutical company. Experience working with COFEPRIS, registering class II & III medical device. Experience working in quality management systems such as ISO 13485 or equivalent. Experience in all aspects of Quality Assurance (QSR, ISO 13485, MDSAP, complaint handing, ISO assessments, risk management, etc.) Skills: Strong organizational skills with ability to prioritize workload. Must be detail-oriented, self-motivated, and able to work independently in a multi-tasking environment. Must have strong presentation and communications skills in both Spanish and English. Must have the ability to work under pressure within time critical deadlines. Strong general computer skills.

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, 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 a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our 100-year history, Olympus has focused on being true to society and making people’s lives healthier, safer and more fulfilling. 

Olympus Canada Inc. (OCI)—a subsidiary of Olympus Corporation of the Americas—manages the Company’s operations and workforce throughout Canada in roles such as sales, marketing, service, and support functions. Based in Richmond Hill, ON,  OCI is committed to developing our employees and supporting our local communities. For more information, visit olympuscanada.com and truetolife.com.
 

Olympus…True To You. True To Society. True To LIFE.

 

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.  EOE Minorities/Females/Veterans/Disabled

 

Posting Notes: || Mexico (MX) || Ciudad de México (MX-CMX) || Mexico, D.F. || 


Job Segment: QA, Quality Assurance, Pharmaceutical Sales, Quality Manager, Performance Management, Quality, Technology, Sales, Human Resources

Apply now »