Senior Regulatory Affairs Expert

3 days ago


Indianapolis, Indiana, United States Lifelancer Full time

Company Overview

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Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. Our goal is to empower individuals to achieve their career aspirations while fostering innovation and growth within our partner organizations.

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Job Summary

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We are seeking an experienced Senior Regulatory Affairs Expert to join our team. This role will be responsible for ensuring the compliance of our medical device products with regulatory requirements worldwide. The ideal candidate will have a deep understanding of international regulations and guidelines, as well as excellent communication and analytical skills.

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Responsibilities

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  • Develop and implement regulatory strategies to ensure product compliance with international regulations and guidelines;">
  • Collaborate with cross-functional teams to identify and mitigate potential regulatory risks;">
  • Prepare and submit regulatory documents, including technical files and design dossiers, to regulatory authorities worldwide;">
  • Evaluate and recommend changes to products, processes, or procedures to ensure regulatory compliance;">
  • Provide guidance and training to colleagues on regulatory matters and best practices;">
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Requirements

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To be successful in this role, you will need:

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  • A minimum of 10 years of experience in regulatory affairs, preferably in the medical device industry;">
  • In-depth knowledge of international regulations and guidelines, such as ISO 13485 and FDA 21 CFR Part 820;">
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external stakeholders;">
  • Strong analytical and problem-solving skills, with the ability to evaluate complex data and make informed decisions;">
  • Proficiency in MS Office, particularly Excel and PowerPoint;">
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What We Offer

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We offer a competitive salary range of $102,000 - $128,000, based on your experience and qualifications. Additionally, we provide a comprehensive benefits package, including medical, dental, vision, and 401(k) matching.

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About Lifelancer

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Lifelancer is a talent-hiring platform dedicated to connecting professionals with opportunities in life sciences, pharma, and IT. Our mission is to empower individuals to achieve their career aspirations while fostering innovation and growth within our partner organizations.

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Apply Now

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If you are a motivated and experienced professional looking to take your career to the next level, please apply now through our website.



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