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EMD Millipore Corporation logo
EMD Millipore Corporation

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Senior Regulatory Experts - Medical Devices

Location

United States

Posted

113 days ago

Salary

$105K - $135K / year

Seniority

Senior

Job Description

Senior Regulatory Experts - Medical Devices

EMD Millipore Corporation

Role Description The Senior Regulatory Expert - Medical Devices will oversee and define roadmap for the global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices to global regulatory agencies and/or to commercial partners. - Oversee and define roadmap for global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices. - Develop and implement strategic frameworks for compliance requirements in various regions including USA, EU, Canada, UK, Switzerland, and others. - Provide regulatory insights and action plans to cross-functional teams to ensure compliance with regulations such as IVDR, FDA 21 CFR 820, and ISO 13485:2016. - Independently author, compile, and maintain technical files and regulatory documentation for timely registrations and renewals. - Review and approve quality management system documentation related to post market surveillance and risk management. - Respond to regulatory inquiries and participate in inspections by authorities and notified bodies. - Implement strategic frameworks for assessing regulatory implications of engineering changes. - Monitor and analyze global regulatory developments and lead regulatory surveillance activities. - Manage regulatory review process for labeling materials ensuring compliance with global regulations. - Provide regulatory assessment for new product development initiatives. - Manage recall or notification actions and ensure effective execution of regulatory vigilance reporting. - Mentor junior team members to support their onboarding and development. Qualifications - Bachelor of Science degree in pharmacy, biology, chemistry, pharmacology, chemical engineering, or a closely related field. - At least seven (7) years of progressively more responsible work experience in global regulatory strategies for in vitro diagnostic medical devices. Requirements - Demonstrated knowledge of medical device or in-vitro diagnostics regulatory compliance. - Ability to author complex regulatory technical documentation for submission to competent authorities. - Experience utilizing software tools for Robotic Process Automation (RPA) solutions. - Ability to conduct regulatory impact assessments and identify regulatory risks early in the process. Benefits - Generous benefits packages.

Job Requirements

  • Bachelor of Science degree in pharmacy, biology, chemistry, pharmacology, chemical engineering, or a closely related field.
  • At least seven (7) years of progressively more responsible work experience in global regulatory strategies for in vitro diagnostic medical devices.
  • Demonstrated knowledge of medical device or in-vitro diagnostics regulatory compliance.
  • Ability to author complex regulatory technical documentation for submission to competent authorities.
  • Experience utilizing software tools for Robotic Process Automation (RPA) solutions.
  • Ability to conduct regulatory impact assessments and identify regulatory risks early in the process.

Benefits

  • Generous benefits packages.

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