TCS regulatory affairs specialist job openings
TATA consultancy services hiring notification for Regulatory Affairs Specialist position. interested and eligible candidates apply now.
Tata Consultancy Services (TCS) is a global technology consulting and outsourcing company that offers a range of services, including regulatory affairs consulting. Regulatory affairs specialists at TCS may be responsible for helping clients navigate the regulatory landscape for their products and ensuring that they are in compliance with all relevant regulations. This may involve working with clients to develop regulatory strategies, preparing and submitting regulatory documents, and communicating with regulatory agencies. In order to work as a regulatory affairs specialist at TCS, you may need to have a relevant degree, such as in a field such as a biology, chemistry, or pharmacology, and some experience in regulatory affairs or a related field. You may also need to be detail-oriented, have strong communication skills, and be able to work effectively in a team
TCS Regulatory Affairs Specialist
Technical/Functional Skills:
The Regulatory Affairs Specialist should provide direct Worldwide Regulatory support to various projects and products. Candidate should support strategic planning and product development efforts, and provide Regulatory support for existing products with respect to product changes/modifications, labeling, and promotional material review and approval.
- Knowledge of FDA regulations and CE, China Registration
- Excellent communication skills, both verbal and written.
- Good organizational skills.
- Good analytical thinking, problem-solving and investigative skills
Roles & Responsibilities:
- Writes, coordinates, and completes the submission of Regulatory documents to FDA and other Regulatory agencies (e.g. EPA). Includes international documents (e.g. tech files, etc.)
- Prepares responses to FDA questions and other Regulatory correspondence
- Provides direct Regulatory support to project teams including the creation of detailed Regulatory Plans
- Includes in-depth team involvement including Core Team membership
- Conducts product labeling and advertising review and approvals
- Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed
- Other activities as assigned including special projects, as needed
- Perform other work-related duties as assigned by the manager of the role
- 510(k)s and determinations as to whether a device modification may trigger the need for a new 510(k)
- European Technical Files, including maintenance and change assessments.
Experience – 5-8 Years of Medical Device Industry RA (Regulatory Affairs) experience
Education – 4-year college degree (Bachelor’s Degree). A Master’s Degree is preferred
Preferred Area of Study – Scientific discipline or Regulatory Affairs
Preferred Related Industry Experience – Pharmaceuticals or Medical Devices
Location of requirement – Kolkata
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