Job
Description
Head of Quality Assurance & Regulatory Affairs (QA/RA) Job Description As the In-charge of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards. Duties/Responsibilities Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. - To lead in new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. - Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements. - Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements - Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Responsible to improve and implement the QMS for ISO 9001:2008 and ISO 13485:2003, European Medical Device Directive MDD 93/42/EEC Follow-up the Indian GMP regulation and ensure compliance of the technical file according to Indian regulation. Responsible for monitoring of critical processes for site in compliance of operations, Quality Management and regulatory affairs. Point of contact between the responsible countries, HQ and Asia regional office in ensuring processes and local activities meet the respective country's regulatory and legal requirements. Management Representative for the company. To be involved in Management review committee and an Executive Board member. - Drives resolution of issues. Communicates issues, impact and outcomes to the management team. - Responsible for ensuring compliance to the submission standards, procedures and policies in India. Author and refine technical documentation necessary to maintain our current CE Markings and to complete a design dossier suitable for submission for new products. Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc. Train all employees to the QMS, and assess skills, knowledge and QMS application. Perform internal audits to assess the company compliance with our QMS. Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information. Work with our Notified Body to maintain current certifications Qualifications 10 years of QMS experience and demonstrated leadership experience. 10+ years of experience in regulatory affairs and quality assurance in the healthcare industry Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Ability to prioritise and make decisions. Good problem-solving abilities able to identify salient issues, consider alternative solutions and evaluate the most appropriate course of action. Strong organisational and team-working skills including commitment and flexibility. Sound work ethics. Looks beyond boundaries of own job to support others. Education Bachelors degree required in a science, engineering field or related discipline. Masters/MBA is a plus
