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.