Regulatory Affairs Professional

7 days ago

Bengaluru, Karnataka, India beBeeregulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Regulatory Affairs Specialist

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Halma is a global leader in life-saving technology companies, driven by a clear purpose. Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology.

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We are a Great Place to Work certified organisation, with an employee centric culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership. We offer a safe and respectful workplace, where everyone can be who they are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

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Responsibilities:

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  • Plan, coordinate and prepare document packages for regulatory submissions and renewals with emphasis on EU Technical Files, MDSAP, and other regulated countries.">
  • Author Technical file documentation to support EU MDR requirements.">
  • Review product labelling (advertising, promotions, IFUs, claims, device labelling) for regulatory compliance.">
  • Contribute to complaint handling process and prepare/submit MDRs and Incidents to appropriate health authorities.">
  • Perform MDR gap assessments and remediation of MDD technical files.">
  • Provide Regulatory support to Manufacturing and R&D to perform significant change impact assessments.">
  • Participate in Change Review board to review and approve Engineering Changes.">
  • Develop and maintain Regulatory Information Management system.">
  • Co-author regulatory plans for new product introduction or product line extensions.">
  • Author Regulatory department procedures, templates.">
  • Provide guidance, training, and direction on regulatory topics to teammates.">
  • Maintain annual facility registrations, device listing, GSI, and GUDID as required by US FDA.">
  • Perform other related duties as assigned.">
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Critical Success Factors

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  • 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 field 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.">
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Qualifications

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  • 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.">
"]},

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