Roles and Responsibilities
Role: Regulatory Affairs Specialist,Pune
Location: Initially Remote till COVID. Thereafter, Pune
Office Time: 11am to 8Pm
The ideal candidate will be a highly organized individual who will take charge of creating, implementing and maintaining the appropriate methods, processes and documents which are required for design controls, regulatory submissions, audit certification and (re)certification.
- Complete all regulatory documentation pertaining to FDA 510k regulations for the approval of clinical devices
- Obtain FDA approval for the clinical device under development
- Technical Documentation
- Interview key IT personnel and read manuals and other material to become familiar with clinical device development technologies and methods
- Observe clinical device development activities to determine operating procedure and prepare detailed documentation on processes
- Organize material and complete writing assignment according to a set of standards regarding order, clarity, conciseness, style and terminology
- Confer with subject matter experts to establish operating instructions, how-to manuals, assembly instructions, and frequently asked questions pages
- Edit, standardize and/or make changes to material prepared by other writers or establishment personnel
- Review published materials and recommend revisions or changes in scope, format, content, and methods of reproduction and binding
- Use photographs, drawings, sketches, diagrams, and charts to increase users understanding
- Maintain records and files of work and revisions
- Analyze developments in specific medical field to determine need for revisions in previously published materials and development of new material
Desired Candidate Profile
- Detail oriented. Must be able to create detailed instructions for others to follow. As a result, must be detailed and precise at every step so that the instructions can be useful
- Understand and able to articulate FDA regulatory standards and requirements
- Writing skills. Must have excellent writing skills to be able to explain technical information clearly
- Research and analytical skills.Must be able to conduct research on topics through personal observation, library and Internet research, and discussions with technical specialists
- Strong communication and interpersonal skills. Must be able to take complex, technical information and translate it for anyone who has a non-technical background. Must be able to interact with colleagues on a regular basis
- Teamwork.Must be able to work well with others
- Degree in Biology, Chemistry, Pharmaceutical Studies or related medical field of study.
- Degree or certificate in Guidance, Compliance, Regulatory Information or equivalent practical experience.
Salary: 15,00,000 - 25,00,000 P.A.
Industry:Medical Devices & Equipment
Functional Area:Research & Development
Role Category:Pharmaceutical & Biotechnology
Employment Type:Full Time, Permanent
UG:B.Tech/B.E. in Any Specialization,B.Sc in Biology, Chemistry,B.Pharma in Pharmacy