Medical Device - Integrated Clinician
Job Description: Integrated Clinician - Medical Devices (Active & Non-Active)
Location: Remote / Hybrid (Flexible)
Employment Type: Contract / Permanent
Industry: Medical Devices, Regulatory Affairs, Notified Body
Key Responsibilities:
- Conduct clinical evaluations and assessments of active and non-active medical devices, ensuring compliance with MDR and IVDR.
- Provide expert clinical guidance in regulatory decision-making, risk assessment, and safety evaluations.
- Review clinical data, post-market surveillance reports, and clinical investigation results.
- Support technical documentation reviews in collaboration with regulatory and engineering teams.
- Contribute to scientific and regulatory justifications for conformity assessments and certification decisions.
- Engage with manufacturers, regulatory bodies, and stakeholders to ensure compliance with evolving medical device regulations.
- Deliver internal training and expert opinions on clinical and regulatory requirements.
Requirements:
- Medical degree (MD, MBBS, or equivalent) OR advanced clinical background (e.g., PhD, MSc, or RN with strong medical device experience).
- Proven expertise in clinical evaluation of medical devices, particularly under MDR 2017/745 and IVDR 2017/746.
- Strong understanding of clinical risk management (ISO 14971), usability (IEC 62366), and biocompatibility (ISO 10993).
- Experience working with Notified Bodies, Competent Authorities, or Regulatory Agencies is highly desirable.
- Excellent analytical, documentation, and communication skills.
Desirable Skills:
- Experience with implantable, software-driven, or high-risk medical devices.
- Background in clinical research, post-market surveillance, or regulatory writing.
- Familiarity with international medical device regulations (e.g., FDA, TGA, MHRA, NMPA).
Why Join?
- Work with a highly respected regulatory team during a transitional period.
- Influence device certification and regulatory compliance at a critical time.
- Flexible working arrangements with opportunities for contract or permanent employment.
If you are an experienced medical professional with a passion for medical device regulation, this is an opportunity to leverage your clinical expertise in a critical regulatory role.
Interested candidates are encouraged to apply or contact EPM for further details.
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