The Head of Quality and Regulatory Affairs is a lead for the Company's quality and regulatory compliance programs and brings a systemic, principled, and balanced approach to risk management, control and governance of quality and compliance matters. This individual will provide operational and strategic input to cross-functional teams and ensure effective communication and constructive working relationships with business partners to enable rapid development of Client's products. Key Result Areas - Strong knowledge of ISO 13485, ISO 27001 (preferred). - Experience with CDSCO guidelines and licensing requirements - Experience with CE certification process for IVD products - Partner and align across the organization to develop and implement strategies to drive success of quality toward goals - Ensure regulatory compliance to all regulations pertaining to Client's products. - Take on the role of Management Representative at Client's - Identify and communicate risks and coordinate development and implementation of resolution plans. - Ensure adherence to applicable regulations including ISO, CDSCO and other domestic and global regulatory authorities. - Assist organizational departments with regulatory review of items including standard operating protocols and test reports - Create, edit, and manage regulatory affairs and quality SOPs - Attend weekly project team meetings as required for regulatory affairs support - Develops quality strategies with Quality Leadership towards the company's current/new products that exceed customer expectations. - Maintenance of regulatory affairs projects tracker - Provide quality and compliance oversight for supply chain and developmental activities, including supporting site identification and qualification, readiness for inspection, audit of vendors/suppliers and creation of quality agreements. - Lead and maintain the quality systems to support product development and future product registrations. - Oversee risk management and change controls systems from early product development to commercialization. - Develop and oversee training programs to ensure compliance with the regulatory authorities. - Trend performance of the Quality Management System and provide metrics to executive leadership for review. - Manages a team of quality and regulatory specialists and grows the team through hiring and talent development and takes an active role in development. - Set ambitious goals for both the team and the broader organization while serving as an inspiring leader for organizational capability and continuous improvement. - Other duties as assigned by the Director of Regulatory Affairs Qualification Required - Bachelor's/Master's Degree in Science or equivalent; Master's Degree will be an asset - 10 + years' experience in IVD/Med Device/Pharma industry with a minimum of 3 years' experience in a leadership role - Proven experience building and sustaining quality systems and responding to regulatory inquiries - Experience working with CDSCO, CE and other domestic and global regulatory authorities. - Knowledge of CDSCO, ISO 13485, ISO 27001, CE IVDR/MDR, FDA, ISO 27001, and other relevant global regulatory standards. Skills Required : - Ability to identify, prioritize and action the most critical and impactful opportunities to continuously improve operations and manage risk. - Outstanding interpersonal and people leadership skills, talent development, assessment and retention and the ability to build and empower a high-performing team. - Ability to facilitate constructive, expedient, and creative problem-solving. - Eye For Business, must understand how businesses work and be knowledgeable in current and possible future policies, trends, practices, technology, and information affecting the businesses. - Proven leadership in managing complex regulatory topics, interactions, including Medical Device Reporting, Vigilance. - Adherence to our organizational values of Integrity, Intensity, Innovation, and Involvement.

Delhi NCR

Head - Quality & Regulatory Affairs - Healthcare 

Head - Quality & Regulatory Affairs - Healthcare  ,Job Description for Head - Quality & Regulatory Affairs - Healthcare  in Blume Ventures in  Delhi NCR for (8-16) years of experience. Apply Now!

Job Description for Head - Quality & Regulatory Affairs - Healthcare  in Blume Ventures in  Delhi NCR for (8-16) years of experience. Apply Now!