Regulatory Affairs Specialist – US FDA

From 6 to 10 year(s) of experience
₹ 15,00,000 - 25,00,000 P.A.

Job Description

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.


FDA Functions

  • 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

Skills Required

  • 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
  • Education
  • Degree in Biology, Chemistry, Pharmaceutical Studies or related medical field of study.
  • Degree or certificate in Guidance, Compliance, Regulatory Information or equivalent practical experience.

Role:Medical Writer

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

Company Profile

RS Consultants

A Canadian healthcare technology company that has developed an innovative, medical-grade, AI-based software and hardware platform for the remote monitoring and management of patients with chronic medical conditions.
Company Info
View Contact Details+

Recruiter Name:Priyanka Soni

Contact Company:RS Consultants