Title/Designation: Sr.Executive- Regulatory Affairs
Reports to: RA Manager
Based at: Ahmedabad
Industry: class III Medical Device
Qualification : Mpharm
Job description
An exciting opportunity in the field of class III / class D Medical devices Certification, QMS & Regulatory Compliances.
About us:
Aegis Lifesciences Private Limited is a leading Indian manufacturer & exporter of medical devices viz., absorbable & non absorbable hemostats. Established in 2008, Aegis have since successfully expanded their business across EU, NHS-UK, CIS, Central America, Russia, LATAM, MENA, SA, SEA regions, with Yo Y growth of >30%, further expanding both the portfolio and geographically. We are looking for aspiring professionals to join our growing team, and be part of our success story.
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 SOP’s 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 4 to 5 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry
● Bachelor’s degree mandatory in relevant field. Master's is preferably.
● Ethical behaviour 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, Power Point, Access, Outlook and Internet data search utilities
Job Types: Full-time, Permanent
Pay: ₹500,000.00 - ₹600,000.00 per year
Work Location: In person