TATA ELXI Life Science Regulatory Affairs Specialist Recruitment

TATA ELXSI Life Science Regulatory Affairs Job

TATA ELXI Life Science Regulatory Affairs Specialist Job for Life science & pharma candidates. Interested & Eligible candidates can apply via their Linkedin account directly below. Experience required for this job.

Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements, and technologies such as artificial intelligence, cloud, and IoT.

Job Title: Regulatory Affairs Specialist

Job code: HLSBU 1148

Required Skills:

• Regulatory knowledge (European Medical device directive and medical device Regulation)
• Familiarity with standards related to Quality Management Systems (ISO 13485, 21CFR Part 820)
• Regulatory experience and Project Management experience, Registration, and submission experience from the medical device industry.
• Excellent written and oral communication in English.
• Ease for reading/creating/modifying documents.
• Able to work with minimal supervision. Self-motivated team player.
• Knowledge of geography-specific regulatory requirements for medical devices (APAC, LATAM, EMEA, Canada, China, Russia.)

TATA Regulatory Affairs Life Science Job

Job Description

• Assists the Regulatory Affairs Manager in ensuring compliance with the requirements set by the EU Medical Device Regulation and other regulatory bodies for medical devices registration across different geographies
• Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia.
• Prepare and review the documentation required for Change submission, Notification, and Re-registration of Medical devices.
• Guide the team in preparing documents for change submission, notification, and re-registration packages of Medical Devices for regulatory agencies’ submission.
• Understands existing technical files/design dossiers/Technical documentation summary by reviewing documentation available for compliance to CE mark of EU and preparing the Country specific STEDs.
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo Ras
• Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.
• Maintaining communication logs and outcomes with regulators and relevant internal or external stakeholders.
• Collects organizes, and maintains files on local, regional and global regulatory intelligence and other related information.
• Research requirements (local, national, international) and options for regulatory submissions, approval pathways, and compliance activities.
• Maintains information systems (electronic and paper) for regulatory information and reports.
• Oversee and ensure maintenance of regulatory licenses renewals in timely manner
  Conveys information to peers, supervisors, and other stakeholders
  Supports the development of internal RA systems and procedures.
• Maintains SOPs related to RA activity and suggests an update of the QMS
  Participated in Regulatory assessment of Engineering/ Design change execution

Job Location: Pune

Experience: 3-10 Years

Qualification: M.Sc./BS/BE/B. Pharm/M. Pharm/Life Science background

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