Specialist II Regulatory Affairs (Mexico)

Las Visión de Conjunto

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

 

At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

 

We are the people behind the people who keep saving lives.

Responsabilidades

The Regulatory Affairs Specialist II is responsible for supporting regulatory activities for Cordis devices to ensure compliance with applicable domestic and international regulatory requirements. This role prepares and supports regulatory submissions, product registrations, change assessments, and regulatory compliance activities under supervision. The position works closely with Manufacturing, Quality, Engineering, Supply Chain, and Product Development teams at the Juarez manufacturing facility to support product development, manufacturing changes, lifecycle management, and global regulatory compliance.

• Perform and document regulatory assessments for manufacturing process, equipment, supplier, material, and design changes; evaluate regulatory impact, review change control documentation, and support determination of global regulatory reporting requirements.
• Partner with Manufacturing Engineering, Quality, Operations, and cross-functional teams to support product development, lifecycle management, manufacturing changes, and regulatory compliance activities.
• Provide regulatory support for investigations, nonconformances, CAPAs, complaints, field actions, audits, inspections, and notified body assessments.
• Interface with regional regulatory teams to support product registrations, approvals, and ongoing market compliance.
• Support continuous improvement of regulatory policies, procedures, and quality system processes to ensure compliance with applicable global regulatory requirements and standards.
• Ensure compliance with FDA, EU MDR, ISO 13485, MDSAP, CE Marking, and other applicable regulatory requirements.
• Perform other duties as assigned.

Calificaciones

Required Qualifications

Requires a minimum 3+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or an advanced degree with no previous professional experience.Where required, the role must hold an appropriate degree in the industry (eg. Legal)

Preferred Qualifications

• Minimum 2 years of regulatory affairs experience in the medical device or pharmaceutical industry.
• Experience supporting manufacturing change assessments, design changes, and lifecycle management activities.
• Working knowledge of FDA regulations, EU MDR, ISO 13485, MDSAP, design controls, risk management, change control, and quality systems.
• Ability to work effectively in a manufacturing and cross-functional environment.
• Strong communication, organizational, and problem-solving skills.
• Experience supporting manufacturing facilities producing Class II and/or Class III medical devices.
• Experience with cardiovascular, endovascular, peripheral vascular, or interventional medical devices.
• Familiarity with global registrations and requirements.

 

 

General Provisions: Company management reserves the right to add, delete or otherwise alter assigned duties at any time.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The minimum qualifications listed are representative of the knowledge, skill, and/or ability required.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.