Strategic Regulatory Mentoring
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01
Course description
Ongoing support for companies making high-impact regulatory decisions: entering new markets, navigating an audit, responding to a crisis or preparing for an investment round. Mentoring does not replace the internal team. It gives the Quality and Regulatory Affairs manager a senior adviser to help decide what to prioritise, how to justify decisions to the board and what to do when circumstances change.
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Course objective
Support leadership in developing and executing high-impact regulatory strategies, accelerating critical decisions, reducing time-to-market risks, optimising compliance investment and turning regulatory affairs into a sustainable competitive advantage for domestic and international growth.
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Course programme
- 01
Strategic assessment of the company's regulatory and quality position
- 02
A tailored roadmap for access to multiple markets, with jurisdiction prioritisation
- 03
Classification, regulatory pathway and technical dossier strategy
- 04
Executive preparation for ANVISA, FDA, MDSAP and MDR audits
- 05
Regulatory governance, KPIs and reporting to the board
- 06
Regulatory crisis management: recalls, critical nonconformities and medical device vigilance
- 07
Regulatory positioning for due diligence, M&A and fundraising
- 08
Recurring individual sessions, with an action plan and deliverable follow-up
- 09
Supplementary material developed by HSC's regulatory team
04
Who can attend?
- Quality and Regulatory Affairs directors and managers
- Founders and C-suite executives at expanding medical device companies
- International manufacturers preparing to enter Brazil and Latin America
- Companies undergoing due diligence, mergers, acquisitions or fundraising
Certification
HSC Global Certificate Recognised by Exemplar Global RTP
Internationally recognised in more than 30 countries by Exemplar Global, with independent validation of the professional's technical competence.
Instructor
Mariana Barreira
Exemplar Global-certified MDSAP Lead Auditor, with more than 8 years' experience implementing ISO 13485 QMS and working across the programme's 5 countries.
- Exemplar Global-certified MDSAP Lead Auditor
- Experience across the programme's 5 countries
- Specialist in ISO 13485 QMS implementation
- More than 8 years' experience