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Regulatory Affairs Specialist
3 days ago
**About Us**
At RESO, we're dedicated to delivering innovative solutions in healthcare and technology. As a leading IT infrastructure and healthcare technology solutions provider, we're expanding our operations in Bahrain.
We're seeking a highly skilled Regulatory Affairs Specialist to handle National Health Regulatory Authority (NHRA) requirements and ensure smooth regulatory operations for our company.
The ideal candidate will have 1+ years of experience in regulatory affairs, preferably in Bahrain. They should possess strong knowledge of NHRA product classification and import regulations.
Key Responsibilities:
- Manage NHRA regulatory affairs, including product classification, registration, and importation processes.
- Ensure compliance with NHRA regulations for medical devices, pharmaceuticals, and healthcare products.
- Prepare and submit regulatory documentation for approvals, renewals, and variations.
- Liaise with NHRA authorities, customs, and relevant stakeholders to ensure smooth importation and distribution.
- Stay updated on changes in regulatory requirements and advise the company accordingly.
- Assist in internal audits and compliance reviews to ensure regulatory adherence.
- Support warehouse operations in regulatory documentation and compliance with storage regulations.
Requirements:
- 1+ years of experience in regulatory affairs, preferably in Bahrain.
- Strong knowledge of NHRA product classification and import regulations.
- Familiarity with regulatory submissions, approvals, and compliance requirements.
- Experience in warehouse regulatory compliance is an advantage.
- Excellent English communication and documentation skills.
- Strong attention to detail and problem-solving abilities.
- Candidates must be based in Bahrain.
- Candidate must hold ROA certification.
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