Job Description

Responsible for ensuring that the company adheres to all relevant laws, regulations enforced by NMRA, SLSI, Consumer Affairs Authority, Import & Export Control department and Department of Ayurveda. This role involves monitoring and assessing the company’s activities to ensure compliance with legal and regulatory requirements, mitigating risk, and ensuring the organization operates with integrity. This position will be the point of contact for all regulatory bodies and will assist in audits, investigations, and compliance reporting.

Responsibilities:

• Obtain the product registrations for new products and maintain the prduct registration renewal of exiting products timely manner at NMRA for medical device and cometics products.
• Obtain and maintain the new product registration and registration renewal of Ayurvedic products at Department of Ayurveda.
• Monitor, analyze, and interpret new and existing regulations enforced by NMRA, SLSI and CAA relevant to the company’s operations.
• Ensure that the company’s business practices comply with applicable laws, regulations, and internal policies.

Compliance:

• Sound knwledege on ISO 9001:2015 QMS.
• Reveiw ISO 9001, ISO 13485 & ISO 22716 manuals timely manner.
• Update and maintain the procedure manual according to the ISO standard.
• Assist in preparing for and managing ISO, GMP and SLS mark audits, inspections, and investigations.
• Conduct internal audits and assessments of operational processes to ensure compliance with regulations.
• Prepare CAPA reports with the root cause analysis.
• Provide compliance training and awareness programs to employees at all levels of the organization.
• Advise and guide internal stakeholders on regulatory requirements, risk mitigation strategies, and best practices.

Communication:

• Communicate compliance and regulatory updates to management, teams, and stakeholders.
• Build and maintain strong relationships with regulatory authorities, ensuring a collaborative approach to compliance issues.

Requirements:

• Bachelor’s degree in science field.
• Diploma in QMS & internal auditor training would be an added advantage.
• Minimum of 2 - 3 years of experience in compliance, regulatory affairs field in cosmetic and sanitary napkin industry.
• Proven experience in preparing and maintaining documents related to product registration submission at NMRA and Department of Ayurveda.
• SOP reviewing and documentation handling relating to the ISO manual.
• Proven experience in internal auditing and CAPA writing.
• Experience with ISO 13485 & ISO 22716 would be an additional advantage.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Ability to collaborate with cross-functional teams and manage multiple priorities.
• Strong attention to detail and organizational skills.

Interested candidates can apply online or email your CV to [email protected]