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Medical Devices Regulatory Affairs jobs

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    • Managing projects within regulatory department.
    • Follow up on technical-regulatory and scientific issues.
    • Provide responses to regulatory questions relating to…
    • Proven experience in Scientific or Medical Affairs within the medical device industry, ideally with a focus on surgical devices.
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    • Experience supporting Class III medical device submissions or equivalently complex regulatory pathways.
    • Understanding of software validation and cybersecurity…
    • Co-ordinate, lead and develop the team of internationally based regulatory consultants engaged in global notification services (ca. 10 - 15 staff).
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    • Strong governance, compliance, and risk management expertise within a global regulatory environment.
    • Complex Problem Solving: Resolve highly ambiguous…
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    • Experience supporting Class III medical device submissions or equivalently complex regulatory pathways.
    • Understanding of software validation and cybersecurity…
    • Support regulatory inspections, audits, and CAPA management.
    • Coordinate the preparation, review, and submission of PSURs, RMPs and ACOs in accordance with…
    • Maintain and develop full regulatory compliance for medical device manufacturing under ISO 13485 and MHRA guidelines.
    • ISO 13485: 1 year (preferred).
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    • Managing regulatory submissions and dossier preparation for medical devices or pharmaceuticals.
    • 3–7 years' experience in regulatory affairs, quality assurance…
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    • Managing regulatory submissions and dossier preparation for medical devices or pharmaceuticals.
    • 3–7 years' experience in regulatory affairs, quality assurance…
    • Develop and implement scalable, efficient processes that meet evolving regulatory and industry standards.
    • Monitor emerging regulatory and industry trends and…
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    • 3–5+ years' experience in regulatory affairs, compliance or quality assurance within medical device or life sciences.
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    • Experience supporting Class III medical device submissions or equivalently complex regulatory pathways.
    • Understanding of software validation and cybersecurity…
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    • Experience supporting regulatory inspections would be advantageous.
    • Private medical insurance (after qualifying period).
    • Access to various well-being platforms.
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    • Strong governance, compliance, and risk management expertise within a global regulatory environment.
    • Complex Problem Solving: Resolve highly ambiguous…
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