QM & RA Manager

We are looking for an experienced Quality Management and Regulatory Affairs Manager (QM & RA) with solid organizational, interpersonal and project management skills. QM & RA Manager will be responsible for coordinating all quality assurance and regulatory compliance activities within the company. The position is responsible for Initial Certification /Renewal audits and the maintenance of the quality system compliant to the ISO 9001:2015, 13485, USFDA, EUMDR and responsible for maintaining clean room standards for medical device & internal/external audits and training activities.

Key & Functional Responsibilities and Authority:

• Subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to sell product globally.
• Manages and oversees the Quality Management System; ensure best and most current practices are leveraged company wide.
• Collaborate internally and externally to determine customer requirements and ensure they are met.
• Develops, maintains, and follows ISO procedures pertaining to medical devices.
• Advises personnel and project teams on quality system and regulatory requirements, coordinates and presents regulatory information, and negotiates with and influences management and colleagues to ensure requirements are met.
• Ensures that quality systems are compliant with all regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed as per current regulatory guidelines/procedures.
• Coordinate with external consulting resources as needed.
• Manage the Internal Audit, CAPA program and Supplier CAPA program.
• Work with process owners for CAPA and internal audit findings and ensure appropriate corrective actions are implemented and verified for effectiveness.
• Provide oversight into the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended structure of the Quality System.
• Having exposure in CDSCO & India Medical device registration process.

Qualification, Skill, and Experience:

• Minimum of 8 to 10 years of core work experience in the Quality System Regulations and Standards for Medical Devices Manufacturing.
• Must have Under Graduation in Engineering /equivalent educational qualification.
• Certified Lead Auditor (ISO13485, 9001:2015).
• Strong knowledge of ISO regulations and procedures for medical devices & CE Certification, USFDA, EUMDR/EUMDU.
• Strong interpersonal, oral, and written communication skills with the ability to effectively communicate with all levels of the organization, customers, and suppliers.
• Presentation skills, technical writing and editing skills.
• Must work well in an early-stage company environment.