Senior Regulatory Affairs Officer

Skills:
Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements, Regulatory Compliance, Title/Designation: Senior Regulatory Affairs Officer Based at: Ahmedabad Industry: Class III Medical Devices Qualification:Postgraduate or equivalent in Pharma/ Medical devise Sector (PhD preferred) Experience: Min. 5-6 years in Certifications and Regulatory documentation Reports to: RA Manager Salary: Commensurate with experience About us: Aegis Lifesciences is a globally recognized leader in the manufacturing and export of medical devices, operating from its state-of-the-art facilities in India. The company specializes in producing high-quality absorbable and non-absorbable hemostats. Since its establishment in 2008, Aegis has successfully expanded its product offerings and global reach, serving even the most quality-conscious markets, including EU, NHS-UK, CIS, Central America, Russia, LATAM, MENA, SA, and SEA. With a remarkable yearly growth rate of over 30%, Aegis has demonstrated significant success in its global operations. Aegis upholds the highest quality standards, holding certifications as ISO:13485, MDSAP, and adhering to GMP standards of multiple countries. The company has received international certificates of CE (Class III medical devices). Furthermore, the Aegis facilities are registered with the United States Food and Drug Administration (FDA), further exemplifying the company's commitment to quality and compliance. About the role: An exciting opportunity in the field of class III / class D Medical devices Certification, QMS & Regulatory Compliances. Responsibilities: Leading new products registration and license renewal in various countries Compliance for international as well as local regulations for various class of medical devices To Lead QA/RA team and ensure quality SOPs within the company Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects Keep abreast of International legislation and guidelines of current product line in India 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 Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes Review of SOPs, BPRs, specifications and change control to ensure compliance Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks 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 Support Commercial Department in business development such as product evaluation and pre-launch activities Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc Candidate requirements: Minimum 5 to 6 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry Bachelors degree in relevant field. Master's is desirable Ethical behavior and high level of integrity Good teamwork, independent and committed to works across functional department Possess good negotiation and dispute resolution skills Demonstrated experience operating in a regulated environment Ability to read, analyze and interpret governmental regulations & reports, scientific or clinical publications and data Ability to write reports, business correspondence, and quality procedures Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities