Job Description

Role - Regulatory Affairs - Medical Devices
Experience - 1 to 3 Years
Location- Madhavaram, Chennai
Budget - As per the industry
Key Responsibilities:
1. Regulatory Submissions: Prepare and submit regulatory documents to authorities for approval, such as new product applications, amendments, and supplements.
2. Compliance: Ensure products meet regulatory requirements, including safety, efficacy, and quality standards.
3. Regulatory Intelligence: Stay up-to-date with changing regulations, guidelines, and industry standards.
4. Risk Management: Identify and mitigate risks associated with products or processes.
5. Collaboration: Work with cross-functional teams, including R&D, Quality, and Manufacturing.
6. Documentation: Maintain accurate and detailed records of regulatory activities, including submissions, approvals, and compliance.
Requirements:
1. Education: Bachelor's degree in a relevant field, such as life sciences, pharmacy, or engineering.
2. Experience: Prior experience in regulatory affairs, quality assurance, or a related field.
3. Knowledge: Strong understanding of regulatory requirements, guidelines, and industry standards.
4. Communication: Excellent written and verbal communication skills.
5. Analytical: Ability to analyze complex regulatory information and identify key issues.
Skills:
1. Regulatory writing: Ability to write clear, concise, and compliant regulatory documents.
2. Project management: Ability to manage multiple projects and prioritize tasks effectively.
3. Attention to detail: Strong attention to detail and ability to ensure accuracy and compliance.
4. Collaboration: Ability to work effectively with cross-functional teams and build strong relationships.
Certifications:
1. RAC (Regulatory Affairs Certification): A certification offered by the Regulatory Affairs Professionals Society (RAPS) that demonstrates expertise in regulatory affairs.
Overall, a Regulatory Affairs professional plays a critical role in ensuring compliance with regulatory requirements and facilitating the development and approval of products.