Regulatory Affairs Manager LATAM
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Regulatory Affairs Manager LATAM
Location: São Paulo Brazil (Hybrid 3 days per week in the office)
Hologic is a leading developer manufacturer and supplier of diagnostic products medical imaging systems and surgical products with a strong emphasis on serving the healthcare needs of women. Our mission is to improve and save lives through early detection of cervical and breast cancer improved diagnosis and less invasive treatments.
We are looking for a Regulatory Affairs Manager LATAM to join our International Regulatory Affairs team and drive our regulatory strategy across the region.
What To Expect:
- 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 companys interests and contributing to policy development.
- Collaborating with colleagues in the US and Europe and being part of a truly international organization focused on womens health.
What We Expect:
- 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.
So Why Join Hologic
We are committed to making Hologic a place where top talent comes to grow. To support your success we provide:
- Continued development opportunities throughout your career including exposure to global projects and cross-functional initiatives.
- The chance to directly impact womens health and patient outcomes across LATAM and beyond.
- We offer a competitive salary and annual bonus scheme; one of our talent partners can discuss specifics during the process.
If you have the right skills experience and mindset and you are excited by the challenge of driving regulatory strategy in a high-impact fast-paced environment - apply today. We look forward to hearing from you.
#LI-RH1
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Hologic is a global champion of women’s health. We integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment.
