Senior Regulatory Affairs Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeRegulatory Full time US$ 1,42,278 - US$ 1,74,095
Job Title: Regulatory Affairs Expert

Key Responsibilities:

  • Develops and implements global regulatory strategies to ensure alignment with organizational objectives.
  • Works under general supervision and broad guidelines consistently exercising independent judgment on matters of significance ensuring adherence to regulatory requirements while maintaining high standards of performance and accountability.
  • Executes, manages, and prepares U.S. FDA 510(k) pre-market notification submissions defining regulatory pathways compiling technical dossiers coordinating cross-functional inputs and driving the process through clearance.
  • Prepares and coordinates FDA Pre-Submissions Q-Subs when strategic feedback is required drafting meeting requests and briefing packages leading interactions with the Agency and ensuring follow-up actions are completed.
  • Monitors and handles potential regulatory impacts on product safety implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks.
  • Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing and UDI Global Trade Identification Number GTIN related activities maintaining processes for regulatory filings licenses and developing technical contribution.

Requirements:

  • Develops substantial understanding of regulator s role in the Quality System with good awareness of product lines disease states and customers possessing general knowledge of business developed through education or past experience.
  • Resolves a wide range of moderate complexity requests in creative ways leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance managing these incidents in Trackwise and ensuring corrective actions are effectively implemented.
  • Creates, reviews, and validates marketing and labeling materials providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards.

What We Offer:

  • Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions making periodic or ad-hoc revisions to Regulatory SOPs and templates.
  • Implements safety and compliance requirements for product development projects and OEM ODM products communicating and integrating regulatory standards into the I.D. organization through memos training sessions and deployment strategies.
  • Administers the compliance protocol process within PDLM and MLD overseeing safety certifications and country-specific approvals to ensure products meet international regulatory standards.

Additional Information:

  • Supports the development of the regulatory plan offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements including product registrations such as CE Marking and clinical evaluations.
  • Develops and facilitates regulatory submissions for both new and existing products solutions ensuring accuracy and completeness to expedite regulatory approval processes effectively preparing regulatory justifications to support submission filing decisions.

Regulatory Expertise:

  1. Regulatory affairs expert with a strong background in regulatory planning and compliance.
  2. Expertise in FDA regulations and industry standards.
  3. Knowledge of global regulatory frameworks and regulatory strategies.

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