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Niko Mangold Email & Phone Number
Regulatory Expert QARA and TD
at
Regulatory Thinking®
LinkedIn matched
✓ Verified August 2026
3 data sources
Profile completeness 86%
Current company
Role
Regulatory Expert QARA and TD
Location
Frankfurt Rhine-Main Metropolitan Area, Germany
Company size
Who is Niko Mangold? Overview
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Quick answer
Niko Mangold is listed as Regulatory Expert QARA and TD at Regulatory Thinking®, a with 4 employees, based in Frankfurt Rhine-Main Metropolitan Area, Germany. AeroLeads shows a matched LinkedIn profile for Niko Mangold.
Niko Mangold previously worked as Regulatory Affairs Manager EMEA at Sprintray Inc. and Regulatory Affairs Specialist EMEA at Sprintray Inc.. Niko Mangold holds Bachelor Of Science - Bs, Medizintechnik from University Of Tübingen.
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Regulatory Thinking®
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Profile bio
About Niko Mangold
Niko Mangold is a Regulatory Expert QARA and TD at Regulatory Thinking®. Colleagues describe them as "I have had the absolute pleasure of working alongside Niko Mangold at Sprintray Europe, where he excelled in his role as Regulatory Affairs Manager. With his extensive knowledge of dental and medical clinical standards, he always brought a unique perspective that ensured compliance and drove business success every time. Niko truly lives up to his aim of bridging the gap between compliance and business goals. His approach to regulatory affairs goes beyond mere adherence to guidelines; he actively seeks creative ways to align compliance initiatives with strategic business objectives. This mindset has been instrumental in advancing complex regulatory projects, streamlining processes, and contributing to the company’s ability to deliver high-quality solutions confidently and precisely within expected timelines. In addition to his technical expertise, Niko is an exceptional colleague. He consistently brings positivity, a collaborative spirit, and a deep commitment to the success of those around him. His guidance has been invaluable, and his dedication to elevating our standards has left a lasting impact. I highly recommend Niko for any opportunity where deep regulatory knowledge, strategic thinking, leadership, and a collaborative mindset are essential."
Current workplace
Niko Mangold's current company
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Regulatory Thinking®
8 roles
Niko Mangold work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs Manager Emea
Current
Mar 2023 - Present
Regulatory Affairs Specialist Emea
Oct 2022 - Mar 2023
Regulatory Expert Qara & Td
CurrentEnsuring that your products meet stringent safety and quality regulations and standards at both the national and international levels.Responsibilities include, but are not limited to:Quality Assurance: Develop, implement, and maintain robust Quality Management Systems (QMS) in accordance with industry standards like ISO 13485, FDA QSR and EU MDR. Conduct internal audits and assist in external audits to ensure compliance.Regulatory Affairs: Strategize and manage regulatory submissions for new product approvals, including FDA 510(k), PMA submissions, and CE Marking applications. Keep abreast of ever-changing global regulatory landscapes and interpret the impact on company products.Technical Documentation: Create and manage comprehensive technical documentation aligned with QMS and regulatory requirements. This includes device master records (DMR), technical files, risk assessments, and validation reports.Cross-functional Collaboration: Work closely with R&D, manufacturing, and other teams to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance.Training: Provide ongoing education to various teams on regulatory requirements and quality standards, promoting a culture of quality and compliance.I have successfully led several major product submissions, resulting in market clearance in various countries. I continually work on improving systems and processes, ensuring not only compliance with but exceeding industry standards for quality and safety.
Apr 2022 - Present
Freelancer In Regulatory Affairs Consulting
Current
Freelance
May 2020 - Present
Quality Assurance / Regulatory Affairs
Elaborate and work independently on the certification of sync2brain as a medical-device-company and on the certification of the medical devices brought into market
May 2020 - Dec 2022
Research Assistant
Sep 2021 - Mar 2022
Studentische Hilfskraft
Unterstützung und selbstständige Arbeit in Therapie und Forschung für die Ambulanz für transkranielle Magnetstimulation sowie das Labor für Brain- and Neuroplasticity
Oct 2019 - Aug 2021
2 education records
Niko Mangold education
Bachelor Of Science - Bs, Medizintechnik
University Of Tübingen
Other, Digital Health
Harvard Business School Online
FAQ
Frequently asked questions about Niko Mangold
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What company does Niko Mangold work for?
Niko Mangold works for Regulatory Thinking®.
What is Niko Mangold's role at Regulatory Thinking®?
Niko Mangold is listed as Regulatory Expert QARA and TD at Regulatory Thinking®.
Where is Niko Mangold based?
Niko Mangold is based in Frankfurt Rhine-Main Metropolitan Area, Germany while working with Regulatory Thinking®.
What companies has Niko Mangold worked for?
Niko Mangold has worked for Regulatory Thinking®, Sprintray Inc., Freelance, Sync2Brain Gmbh, and Universitätsklinikum Tübingen.
How can I contact Niko Mangold?
You can use AeroLeads to view verified contact signals for Niko Mangold at Regulatory Thinking®, including work email, phone, and LinkedIn data when available.
What schools did Niko Mangold attend?
Niko Mangold holds Bachelor Of Science - Bs, Medizintechnik from University Of Tübingen.
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