Chief Regulatory Compliance Officer

1 dia atrás

São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro MX$2.500.000 - MX$3.500.000
Regulatory Affairs Leader

We are seeking a seasoned Regulatory Affairs expert to spearhead the development and execution of global regulatory strategies for our business vertical.

The ideal candidate will possess a strong background in medical technology regulation, including pre-market approval processes, clinical trial oversight, and interaction with regulatory bodies both in the US and internationally.

  • Regulatory Strategy Development: Develop and execute regulatory strategies, identify preferable markets, and ensure compliance with relevant national and international regulations.
  • Regulatory Advocacy and Thought Leadership: Engage with regulatory authorities, industry bodies, and policymakers to shape the regulatory landscape for biotech and advocate for policies promoting innovation while ensuring patient safety.
  • Policy Analysis and Guidance: Provide analysis on global regulatory policies and advise executive leadership on potential regulatory risks and opportunities.
  • Product Development: Provide premarket regulatory strategy guidance and advise on risk assessments, biocompatibility, and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices.

Requirements:

  • Experience: Minimum of 10 years in regulatory affairs, with a strong background in neurotechnology and implantable devices.
  • Skills: Proven ability to interact effectively with US and international regulators, experience with PMA processes, 510(k) submissions, and clinical trials.
  • Expertise: Preparing complex regulatory documents and other major regulatory submissions, scientific advice and approvals for clinical trials.

What We Offer:

  • Collaborative Environment: Work closely with internal teams and partners to ensure alignment with regulatory requirements.
  • Opportunities for Growth: Contribute to shaping the regulatory landscape for biotech and drive technological advancements.

About the Role:

This is an exceptional opportunity to join a dynamic team and make a meaningful impact in the biotech industry. If you have a passion for regulatory affairs and a desire to drive innovation, we encourage you to apply.

Key Responsibilities:

  • Develop and implement global regulatory strategies
  • Interact with regulatory authorities and industry bodies
  • Analyze global regulatory policies
  • Provide guidance on product development and regulatory compliance

Why This Role Matters:

This role is critical to ensuring the success of our business vertical and driving technological advancements in the biotech industry.

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