P2 - Specialist, Commercial Quality and Regulatory Affairs

Radiometer; México; On-site; MXN 600,000 - 800,000; Full time

Benefits offered by this job

Bonus/incentive pay

Health insurance

Pension plan

Paid time off

Job summary

Beckman Coulter Diagnostics in Mexico City seeks a Specialist, Commercial Quality & Regulatory Affairs to support QA and regulatory processes across LATAM from an on-site role.

You will prepare registration dossiers, support post-market vigilance, audits, and provide technical documentation for regulatory submissions while collaborating with Tender, Operations and Marketing.

Qualifications

• Bachelor’s degree in pharmacy, biology, biomedical engineering or chemistry.
• Experience >2 years in quality assurance (regulatory affairs experience is an added advantage).
• Knowledge in Mexico and other LATAM medical device regulations.
• English language (basic) to read documents and communicate with global organization.
• Experience with Quality Management Systems and GMP regulation.

Responsibilities

• Review and ensure that the Quality Management System is up to date and aligned with current sanitary regulations.
• Support warehouse GMP oversight and processes improvements by taking part in the internal quality audits, external sanitary agency audits, suppliers and distributors audits.
• Prepare the technical dossiers to support registration for new products and license renewals and support Field Actions and other post market vigilance activities.
• Evaluate design changes against regulatory requirements to support the modifications in the registration license and organize a database of legal documents for tenders and internal regulatory processes.
• Support our Sales Channel Partners by providing the technical documentation for their regulatory submissions.

Skills

Communication

Analytical

Teamwork

Problem solving

Education

Bachelor’s degree in pharmacy, biology, biomedical engineering or chemistry

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

Specialist, Commercial Quality & Regulatory Affairs

The Specialist, Commercial Quality & Regulatory Affairs is responsible for supporting quality and regulatory processes such as product registration (New Registers, Amendments, Renewals, etc.), providing support to internal customer requirements, control of Legal and Technical Documents, conducting post market vigilance, performing administrative activities to support internal departments such as Tender, Operations and Marketing/Commercial, support with customer complaints, Quality Management System documentation and processes, internal and external quality audits for distributors and supplier audits.

This position reports to the Senior Manager, Commercial Quality Assurance LATAM and is part of Quality and Regulatory Team located in Mexico. The role will be an on-site role supporting Mexico, Puerto Rico/Caribbean, and other LATAM countries.

Responsibilities

• Review and ensure that the Quality Management System is up to date and aligned with current sanitary regulations.
• Support warehouse GMP oversight and processes improvements by taking part in the internal quality audits, external sanitary agency audits, suppliers and distributors audits.
• Prepare the technical dossiers to support registration for new products and license renewals and support Field Actions and other post market vigilance activities.
• Evaluate design changes against regulatory requirements to support the modifications in the registration license and organize a database of legal documents for tenders and internal regulatory processes.
• Support our Sales Channel Partners by providing the technical documentation for their regulatory submissions.

Essential Requirements

• Bachelor’s degree in pharmacy, biology, biomedical engineering or chemistry
• Experience >2 years in quality assurance (regulatory affairs experience is an added advantage)
• Knowledge in Mexico and other LATAM countries medical device regulations.
• English language (basic) to read documents and communicate with global organization.
• Experience with Quality Management Systems and GMP regulation

Preferred Experience

• Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role Not applicable for this role
• Ability to work in a cross-functional and teamwork environment.
• Communication, analytical, strong focus and problem-solving skills.
• Knowledge of in vitro diagnostics products and technologies.

Benefits

• Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
• Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
• Check out our benefits at Danaher Benefits Info.
• This job is also eligible for bonus/incentive pay.
• We offer a comprehensive package of benefits including paid time off, medical/dental/life insurance and pension plan to eligible employees.

We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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