The BI Head is responsible for Quality Assurance, Regulatory affairs, SAP and IT. . The BI Head is also responsible for advising and consulting with stakeholders about compliance with applicable ISO 13485:2016 regulations, EU regulations, and other applicable standards for all products manufactured by the organization. The BI Head will research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the regulatory affairs and quality assurance team.
Report To: MD
Roles & Responsibility
- Create and Maintain regular lines of communication with QA &RA teams to promote quality awareness, regulatory partnership, and harmonization of quality processes.
- Will be appointed as Management Representative.
- Conduct internal audits and provide guidance regarding best practices and continuous improvement.
- Promote audit readiness, prepare quality teams for audits by external bodies, including’s 13485:2016, and facilitate audits as needed.
- Support monitoring, measurement, and effectiveness of the JDHL’s quality systems to continuously improve performance.
- Partner with QA teams on the execution of corrective action plans, tracking and verifying that deficiencies are corrected.
- Ensure that quality system requirements are effectively established and maintained in accordance with applicable medical device regulations ISO 13485 / 21 CFR 820 compliance for JDHL products, including registrations, listings, license amendments, 510(k) submissions, letters to file, labelling, UDI, and other requirements.
- Work with MD to respond to regulatory body enforcement inquiries.
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies.
- Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of medical devices ·.
- Staying informed about any changes in legislation etc. & Update the changes as per regulatory legislation and guidelines.
- Maintain expert current knowledge of FDA, ISO 13485:2016, 21CFR820, and other applicable foreign country regulations, legislation, best practices, and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or a work plan and complete according to deadline.
- Delivering high-quality reporting and insights through automation, insight and challenge to business areas.
- Designing and managing underlying data sources to allow quick and efficient data extracts to support analysis.
- Other duties as assigned.
- Manage information technology and computer systems.
- Plan, organize, control and evaluate IT and electronic data operations.
- Design, develop, implement and coordinate systems, policies and procedures.
- Ensure security of data, network access and backup systems.
- Act in alignment with user needs and system functionality to contribute to organizational policy.
- Identify problematic areas and implement strategic solutions in time.
- Audit systems and assess their outcomes.
- Preserve assets, information security and control structures.
- Handle annual budget and ensure cost effectiveness.
- Oversee SAP project to provide metrics for reporting to executive team on business case ROI. ·
- SAP Accuracy review.
- Provide Cost Benefit Analysis (CBA) on selected business processes to assemble input into business case.
- Develop and oversee detailed project plans.
- Identify, analyze and recommend business systems solutions to management having broad business impact.
Qualification and Skills
- Experience: At least more than 5 years’ experience in Regulatory Affairs. Thorough understanding of regulatory requirements for medical device products industry.
- Experience in preparation, submission of regulatory submissions for countries in scope.
- Skilled in ISO 13485, U.S. Food and Drug Administration (FDA), CE, Health Canada, Post market surveillance, UDI, Corrective and Preventive Action (CAPA), Change Control, Deviation, AMV, Sterilization process, Process validation, OOS, QMS, etc.
- Establishing Quality management system in accordance with ISO 13485 and 21 CFR 820.
- Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
- SAP Knowledge
- IT understanding
- Good understanding and application of knowledge of regulatory guidelines and requirements of the countries.
- Effective planning, organization, and leadership skills.
- Able to engage effectively with regional/global corporate headquarters to get the support and resources necessary to successfully execute the RA strategy and plan.
- Strong analytical & outstanding problem-solving skills.
- Excellent project management skills and ability to manage multiple priorities concurrently.
- Six Sigma Green Belt minimum