Analyst Regulatory Affairs Fixed Term 12 Months

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at internal pre-identified candidate for consideration has been identified. However all applications will be considered.

We are searching for the best talent for Analyst Regulatory Affairs.

Purpose:

Support the preparation review and follow-up of regulatory submissions for medical devices ensuring compliance with applicable regulations before health authorities such as COFEPRIS enabling timely approvals and maintenance of product registrations.

You will be responsible for:

• Prepare and compile regulatory documentation for COFEPRIS submissions (registrations renewals changes).

• Follow up on submissions with regulatory authority (COFEPRIS).

• Support interpretation of local and international regulations.

• Support coordination of requests and activities with cross-functional teams.

• Maintain updated regulatory files and databases.

Qualifications / Requirements:

• Bachelors degree in Chemistry Pharmaceutical Chemistry Pharmacy Biomedical Engineering Biotechnology or related field.

• Minimum 1 year of experience in regulatory affairs quality or medical device industry.

• Mexican medical device regulations (COFEPRIS).

• Medical device classification.

• NOMs and standards aplicable.

• Intermediate-advanced English (technical reading required).

• Intermediate Excel skills (data tracking pivot tables basic formulas reporting).

• Attention to detail.

• Organizational and documentation skills.

• Effective communication.

• Team collaboration.

• Proactivity.

• Learning Agility.

• Adaptability.

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