Regulatory Affairs Specialist for Medication and Medical Devices in Brazil
Há 1 mês
**Job Title:** Regulatory Affairs Specialist for Medication and Medical Devices in Brazil
About the Role:
Sully's Steamers Johnson City is seeking a highly skilled Regulatory Affairs Specialist to join our team in Brazil. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with local regulations and facilitating the approval of new products.
This position requires a strong understanding of Brazilian regulations and guidelines governing medication and medical devices. You will be responsible for coordinating regulatory activities, developing strategies, and implementing processes to ensure timely commercialization of new or modified products.
As a Regulatory Affairs Specialist, you will work closely with cross-functional teams to gather information, assemble documentation, and prepare submissions to government regulatory agencies. Your expertise will be essential in providing regulatory advice, resolving issues, and ensuring compliance with relevant regulations.
Key Responsibilities:
- Coordinate regulatory activities, including submitting applications, responses to regulatory agency questions, and other correspondence.
- Develop and implement regulatory strategies, plans, and processes to ensure compliance with local regulations.
- Work with cross-functional teams to gather information, assemble documentation, and prepare submissions to government regulatory agencies.
- Provide regulatory advice and support to project teams, ensuring that all products meet regulatory requirements.
- Maintain up-to-date knowledge of local regulations, guidelines, and industry developments.
- Collaborate with regulatory agencies to resolve issues, address queries, and facilitate approvals.
Requirements:
- Bachelor’s degree in a relevant field, such as life sciences, law, or business.
- Minimum 4 years of experience in regulatory affairs, preferably in the pharmaceutical or medical device industry.
- Fluent in English and Portuguese, both written and verbal. Spanish is an asset.
- Strong analytical, problem-solving, and communication skills.
- Able to work independently and collaboratively as part of a team.
- Demonstrated ability to handle multiple projects, prioritize tasks, and meet deadlines.
What We Offer:
- Competitive salary range: R$120,000 - R$180,000 per year.
- A dynamic and supportive work environment.
- Ongoing training and professional development opportunities.
- A collaborative team culture that values innovation and creativity.
If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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