Regulatory Affairs Specialist

3 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,57,39,000 - ₹ 2,09,22,000

Halma plc, a global group of life-saving technology companies driven by a clear purpose, offers an exciting opportunity as an Regulatory Affairs Executive. We are seeking a skilled professional to join our team.

About the Role

The successful candidate will be responsible for planning, coordinating, and preparing document packages for regulatory submissions and renewals. This includes emphasis on EU Technical Files, MDSAP, and other regulated countries. The role also involves authoring technical file documentation to support EU MDR requirements, reviewing product labeling for regulatory compliance, contributing to complaint handling processes, and performing MDR gap assessments.

Key Responsibilities
  • Planning and coordination of document packages for regulatory submissions and renewals
  • Authoring technical file documentation to support EU MDR requirements
  • Reviewing product labeling for regulatory compliance
  • Contributing to complaint handling processes and preparing submissions to appropriate health authorities
  • Performing MDR gap assessments and remediation of MDD technical files
  • Providing regulatory support to manufacturing and R&D teams
  • Participating in Change Review boards to review and approve engineering changes
  • Developing and maintaining regulatory information management systems
  • Co-authoring regulatory plans for new product introductions or product line extensions

The ideal candidate will have:

Requirements
  • In-depth knowledge of medical device regulations and standards, such as FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO 14971
  • Experience in Ophthalmology or surgical instrument fields preferred
  • Experience in medical device development, quality assurance, or regulatory affairs is highly desirable
  • Strong analytical and problem-solving skills with the ability to assess complex technical issues
  • Excellent communication and collaboration skills to work effectively with cross-functional teams
  • Detail-oriented and well-organized, with the ability to manage multiple tasks and priorities simultaneously
  • Familiarity with documentation and submission requirements for regulatory bodies is an advantage
Qualifications
  • BS/BA in Engineering, Life Sciences, or an equivalent technical field
  • MS in Regulatory Affairs or RA/QA certifications a plus
  • 5-8 years of experience in Quality or a regulated industry is preferred
Why Join Us?

We offer a safe and respectful workplace where everyone can be themselves and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes. We nurture entrepreneurial spirits and empower them to think beyond possibilities, discover, shape, and build their own unique stories. We promote and support non-linear career growth for the right talent. We believe in leadership at all levels to bring our purpose to life. Everyone at Halma makes an impact, and so do you when you join us.

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