Job Summary

The Regulatory Affairs Product Specialist ensures that medical devices comply with all relevant regulations and standards. This role involves being responsible of the technical documentation conformity according to regulatory framework, and providing guidance on regulatory requirements throughout the product lifecycle.

Key Responsibilities

Documentation: Prepare and maintain regulatory documentation according to MDR 2017/745

Regulatory Compliance: Responsible of the technical documentation conformity with the regulatory framework. Ensure products meet all applicable regulatory requirements, (including local, regional, and international regulations), standards and internal processes.

Regulatory Strategy: Develop and implement regulatory strategies for product development, approval, and change control.

Review: Evaluate product promotional materials, labeling, and specifications for compliance.

Communication: Liaise with internal functions teams regarding submissions, compliance, and audits.

Support: Provide regulatory input during product development and lifecycle planning.

Training and Education: Train and educate internal teams on regulatory requirements and best practices to ensure ongoing compliance.

Qualifications

Education: Master’s degree in a relevant field such as biology, chemistry, pharmacology, or regulatory science, Strong knowledge of MDR 2017/745 and technical documentation requirements.

Experience: 4-5 years of experience in regulatory affairs in medical devices

Skills: Strong analytical and problem-solving skills, excellent written and verbal communication, attention to detail, and the ability to interpret complex regulations. Fluent in English.

Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.