Regulatory Affairs Director for Global Biotech Expansion
hace 2 días
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Job Title: Regulatory Affairs Director for Global Biotech ExpansionSalary: $180,000 - $250,000 per yearWe are seeking an experienced Regulatory Affairs Director to lead our global biotech expansion efforts. This key role will be responsible for designing and executing regulatory strategies to ensure compliance with national and international regulations.
Key Responsibilities:- Develop and execute regulatory strategies to enable market access for our company in the Brain-Computer Interface (BCI) space.
- Lead interactions with regulatory agencies, industry bodies, and policymakers to shape the regulatory landscape for biotech.
- Analyze global regulatory policies and provide guidance on potential risks and opportunities.
- Collaborate with internal teams to ensure alignment with regulatory requirements and proactively address emerging challenges.
- Minimum 10 years of experience in medical technology regulation, with a strong background in neurotechnology and implantable devices.
- Proven ability to interact effectively with US and international regulators, including the FDA.
- Experience with PMA processes, 510(k) submissions, and clinical trials.
- Competitive salary range: $180,000 - $250,000 per year.
- Opportunities for professional growth and development.
- A dynamic and innovative work environment.
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