Regulatory Affairs Manager LATAM

Brazil·São Paulomid

OtherRegulatory Affairs Manager

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Quick Summary

Overview

Regulatory Affairs Manager, LATAMLocation: São Paulo, Brazil (Hybrid – 3 days per week in the office) Hologic is a leading developer, manufacturer, and supplier of diagnostic products,

Technical Tools

OtherRegulatory Affairs Manager

Own and execute regulatory strategies for medical devices and/or IVDs across the LATAM region in alignment with global and regional business objectives.
Collaborate closely with cross-functional colleagues locally and globally.
Develop and drive product registrations, submissions, and approvals throughout LATAM, ensuring full compliance with local regulatory requirements.
Monitor, interprete and communicate regulatory changes and trends across LATAM, translating them into clear, actionable guidance for internal stakeholders.
Build and maintain strong relationships with regulatory authorities, industry associations, and other external bodies.
Partner with commercial teams and managing the regulatory interface with indirect channels and distributors, ensuring that business strategies and promotional activities remain compliant.
Lead the investigation and resolution of regulatory issues and non-conformities, including defining and implementing corrective and preventive actions (CAPAs).
Conduct regulatory assessments of new regulations, technologies, and product lines to support market access and expansion across the region.
Represent Hologic in industry forums, working groups, and regulatory meetings, advocating for the company’s interests and contributing to policy development.
Collaborating with colleagues in the US and Europe and being part of a truly international organization focused on women’s health.

Requirements

~2 min read

Minimum 7 years of relevant experience in Regulatory Affairs and Quality Assurance within the medical device and/or IVD industry.
A growth mindset: you are curious, open to feedback, and committed to continuous learning and improvement.
Strong knowledge of LATAM regulatory requirements for medical devices and/or IVDs, with a proven track record of successful registrations, submissions, and approvals in the region.
Good understanding of EU MDR / IVDR and US FDA regulations and how they interface with global regulatory strategies.
Demonstrated experience working with indirect channels and distributors, guiding them on regulatory boundaries and ensuring compliant practices.
Fluent Portuguese (spoken and written); Spanish is a strong plus.
Experience working in a multinational company, ideally with US- or Europe-based headquarters.
Strong analytical and problem-solving skills, with a strategic mindset to navigate complex regulatory and business challenges.
Proven ability to operate under high pressure in a fast-paced environment, with high expectations for speed of execution and quality of outcomes.
A can-do attitude and positive, proactive approach to overcoming obstacles and delivering results.
Strong communication, influencing, and negotiation skills, with the ability to clearly explain regulatory requirements and decisions to non-regulatory stakeholders.
Demonstrated ability to hold the line on compliance when facing commercial pressure, while working collaboratively to find compliant and business-supportive solutions.