JOB PURPOSE:

The role will ensure that products meet rigorous scientific, legal, safety, and quality standards in pharmaceuticals and medical devices manufacturing. The incumbent will oversee the entire product lifecycle from ideation to launch and post-market evaluation, focusing heavily on regulatory compliance and quality operations.

DUTIES AND RESPONSIBILITIES:

• Preparing Device Master File and all other required documents for submission for product registration, including IVDSs such as RDTs and molecular diagnostics
• Preparing product dossiers for the WHO prequalification of the In Vitro-Diagnostics program. Preparing and submitting regulatory/ technical dossiers for medical devices and rapid diagnostic test kits for WHO prequalification, national regulatory bodies, and international markets i.e. market-specific regulatory submissions.
• Preparing a technical documentation file and providing the documentation to support European Authorization and CE marking.
• Maintaining the changes to the Regulations/Products/Sites and making necessary submissions to maintain compliance with global regulations.
• Designing and coordinating the execution of validation & evaluation studies at different levels, like performance, quality, advancement, robustness for assay conditions.
• Providing medical device registration support to ensure the timely launch of new products such as IVDs, medical devices, and other therapeutics.
• Review the external evaluation reports (e.g., WHO, CE, FDA evaluation results) and prepare a response to the queries raised.
• Handling Post Approval Change (PAC) from applicable regulatory authorities
• Perform product risk analysis and assessment per ISO 14971 and ISO 13485 of products.
• Participation in clinical trials, documentation, and compilation of the clinical evaluation reports.
• Support QMS documentation and regulatory compliance activities in
• Outlining requirements for labelling, storage, and packaging.
• Preparing and reviewing regulatory submissions, including Technical Files, Design Dossiers, and Device Master Files (DMF).
• Coordinating with operations, research & development departments, regarding production design and development to ensure compliance with regulations.
• Assisting with the development of standards for the company’s operating and production procedures.
• Train cross-functional teams (RA/QA/QC/Production/Maintenance/Warehouse/HR) on regulatory compliance best practices in product certification
• Planning, undertaking, and overseeing product trials, trial data analysis, and regulatory inspections.
• Coordination of technology transfer projects to ensure compliance with applicable stringent regulatory authorities, such as the WHO, USFDA

QUALIFICATIONS & EXPERIENCE

• Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry, or related field preferred.
• Minimum 10 years of hands-on experience in WHO, EU, or Asian product certification processes.
• Minimum of 5 years’ leadership experience as a supervisor of product certification teams.
• Proven track record in scaling up product certification, compliant with GMP/ISO 13485.
• Minimum 6 years in diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership.
• Proven truck record of leading a WHO PQ certification process of at least 3 products.

KEY COMPETENCIES

• Product Management Expertise: Strong analytical and strategic thinking skills to manage the product roadmap and development process.
• Regulatory Knowledge: In-depth knowledge of the WHO PQ, NDA, and other regulatory processes is critical.
• Professional certifications in product management or quality management
• Effective communication, leadership, and problem-solving skills are necessary to manage diverse stakeholders and teams.

• Preparing Device Master File and all other required documents for submission for product registration, including IVDSs such as RDTs and molecular diagnostics
• Preparing product dossiers for the WHO prequalification of the In Vitro-Diagnostics program. Preparing and submitting regulatory/ technical dossiers for medical devices and rapid diagnostic test kits for WHO prequalification, national regulatory bodies, and international markets i.e. market-specific regulatory submissions.
• Preparing a technical documentation file and providing the documentation to support European Authorization and CE marking.
• Maintaining the changes to the Regulations/Products/Sites and making necessary submissions to maintain compliance with global regulations.
• Designing and coordinating the execution of validation & evaluation studies at different levels, like performance, quality, advancement, robustness for assay conditions.
• Providing medical device registration support to ensure the timely launch of new products such as IVDs, medical devices, and other therapeutics.
• Review the external evaluation reports (e.g., WHO, CE, FDA evaluation results) and prepare a response to the queries raised.
• Handling Post Approval Change (PAC) from applicable regulatory authorities
• Perform product risk analysis and assessment per ISO 14971 and ISO 13485 of products.
• Participation in clinical trials, documentation, and compilation of the clinical evaluation reports.
• Support QMS documentation and regulatory compliance activities in
• Outlining requirements for labelling, storage, and packaging.
• Preparing and reviewing regulatory submissions, including Technical Files, Design Dossiers, and Device Master Files (DMF).
• Coordinating with operations, research & development departments, regarding production design and development to ensure compliance with regulations.
• Assisting with the development of standards for the company’s operating and production procedures.
• Train cross-functional teams (RA/QA/QC/Production/Maintenance/Warehouse/HR) on regulatory compliance best practices in product certification
• Planning, undertaking, and overseeing product trials, trial data analysis, and regulatory inspections.
• Coordination of technology transfer projects to ensure compliance with applicable stringent regulatory authorities, such as the WHO, USFDA

• Product Management Expertise
• Regulatory Knowledge
• Professional certifications in product management or quality management
• Effective communication
• Leadership
• Problem-solving skills

• Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry, or related field preferred.
• Minimum 10 years of hands-on experience in WHO, EU, or Asian product certification processes.
• Minimum of 5 years’ leadership experience as a supervisor of product certification teams.
• Proven track record in scaling up product certification, compliant with GMP/ISO 13485.
• Minimum 6 years in diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership.
• Proven truck record of leading a WHO PQ certification process of at least 3 products.