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.