Key Position in Central Team of Motherson Health & Medical to shape, plan and execute Regulatory strategies for Products as part of Organic growth as well as interfacing with Inorganic growth opportunities to assess regulatory risks and build a mitigation plan to enable the company scale up the business. Closely work with top management at Motherson Health & Medical Corporate for Regulatory Affairs & Quality Management Systems deployment and adherence at various locations of Motherson.
Provide Leadership and coordinate with cross functional teams to deliver Safe,Effective & Regulatory compliant Products to customers following the QCDMSES (quality, cost, delivery, development, management, safety, environment & sustainability) process.
Ensure right level of Processes, training and personnel are placed to support all Regulatory deliverables from Product Development, Go to Market, Product Certifications & Post Market Regulatory expectations. To be one point of contact for all communications for internal and External regulatory bodies to obtain and maintain Certifications for Site and Medical devices and components.
Provide leadership and direction for the leadership functions. Ensure Compliant Quality Culture, open and effective communication in the Business around global locations. • Liaison with all external regulatory & certifying bodies to enable certifications and its audits. • Periodic reporting of health of the Regulatory Status of Products at site to the top management. • To ensure pre-market and Post Market regulatory expectations for products are met. • Ensure the manufacturing facility & Product Development teams follows GDP, GMP, technically sound, safe and environmentally acceptable manner by complying with Quality Policy & ISO 9001,13485 requirements and other relevant regulations and best practices. • Ensure Quality Culture Mindset development at the site. • Ensuring Training within organization in adherence to the applicable regulations & enabling the same within the QMS established. • Documentation support to facilitate ISO 13485, FDA license and Schedule M compliance. • Select, manage coach and develop staff, in line with Motherson values and HR requirements and procedure. • Effectively engage in NPI activity to outline the component, product or services regulatory requirement from day one. To build and develop best in class quality regulatory team in Health & Medical division including its supplier base.
