Strategic Regulatory Affairs Manager

2 days ago

Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 22,08,000 - ₹ 30,16,000
Regulatory Affairs Specialist Job

A highly respected medical device firm requires a skilled Regulatory Affairs Specialist to lead the company's regulatory project approvals in various countries. This pivotal role involves strategic development, implementation, and maintenance of global market requirements for our products.

  • About the Role:
  • This is an exceptional opportunity for a seasoned professional to oversee the entire regulatory process, from planning to execution, ensuring seamless integration with our overall business strategy.
  • Key Responsibilities:
  • Develop and implement a comprehensive regulatory compliance strategy to meet global market needs.
  • Maintain accurate records of regulatory approvals and registrations across multiple regions.
  • Draft, review, and maintain departmental policies and procedures, including post-approval changes, labeling, and IFU requirements.
  • Provide guidance on language translation needs and marketing claims.
  • Supervise a team of RA coordinators to ensure smooth execution of tasks.
  • Skill Requirements:
  • Excellent understanding of regulatory affairs and the medical device industry.
  • Superior communication, project management, and leadership skills.
  • Ability to work independently and collaboratively as part of a dynamic team.

Benefits of Working With Us:

  • We offer a collaborative, family-style culture that fosters innovation, quality, and clinical value.
  • Ongoing opportunities for professional growth and development.
  • A diverse and challenging work environment that drives results.

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