Job DescriptionRole - Regulatory Affairs - Medical DevicesExperience - 1 to 3 YearsLocation- Madhavaram, ChennaiBudget - As per the industryKey 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.
