Regulatory Specialist

1 month ago

Gurugram, India Hollister Incorporated Full time

Summary:

As an individual contributor, the function of a Regulatory Affairs Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products.  The individual will prepare and submit documentation needed for registrations globally. This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion.  

 

Responsibilities:

  • May represent Regulatory Affairs in project teams with assistance on the development of regulatory strategies for new product development and product changes.
  • Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements.
  • Assists with the preparation, review, and approval of department SOP’s.
  • Assists with regulatory advice to project teams.
  • Respond to regulatory authorities’ queries within defined deadlines.
  • Maintain regulatory files in a format consistent with requirements and stored in defined electronic system.
  • Develop and initiate regulatory project plans.
  • Manage regulatory activities relating to specific portfolio of products/projects (product owner)
  • May review labeling and promotional material for compliance with local regulations.
  • Maintain annual licenses, registration renewals and listings with various health authorities.
  • Participates in the monitoring of proposed regulations on a federal and state level (domestic and international) that affects the viability of Hollister Business
  • Participates in the monitoring of existing and proposed standards (ISO, EN, BSI, etc.) that are applicable to Hollister Business

Essential Functions of the Role**:

  • Prolonged sitting, typing and standing

Work Experience Requirements

  • Number of relevant years of experience necessary: 5-8

 

  • Five years in a Regulated industry experience minimum. Higher education may compensate for years of experience.

 

  • 2+years of regulatory experience

 

Education Requirements

  • Bachelor's degree in scientific discipline required, M.S. preferred.

 

Specialized Skills/Technical Knowledge:

  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • Basic Knowledge and understanding of USA and EU regulations. 21CFR820 & EUMDR
  • Exercise independent judgment
  • Strong written and verbal communication skills
  • Knowledge of regulations and design controls
  • Developing negotiation skills and problem-solving skills
  • Ability to work closely with people at multiple levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
  • Technical system skills (e.g., word processing, spreadsheets, databases, online research)
  • Ability to manage or lead multiple small projects and deadlines.
  • Ability to identify compliance risks and escalate when necessary.

 

Local Specifications (English and Local Language):

  • English

 

Location : Gurgaon

Mode : Hybrid

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