Chief Operations Officer

Private Advertiser
Melbourne
CBD & Inner Suburbs
CEO & General Management
COO & MD
Full time
Posted 13d ago

We are a medical device company, a leader in our field and our technology is used for medical, translational and pre-clinical applications. 

We are looking for an accomplished and driven individual to join our team as a Chief Operations Officer on a full time permanent role as our company enters into a growth phase.

We are seeking a professional: 

  • with a tertiary degree (engineering, science and/or medicine). Post graduate qualifications preferred;
  • who has project management experience, ideally in product development or research & development;
  • who has strong technical knowledge of ISO13485, ISO14971, FDA CFR 21 Part 820, CE Mark, GMP, GCP, IEC62304 and IEC60601;
  • who has experience with regulatory and notified bodies;
  • who has financial literacy, P&L responsibilities and commercial acumen.

Your key responsibilities will include; 

  • all operational activities of the company, including R&D, Production, Quality, Regulatory, Clinical Affairs, Risk, IP (including patent portfolio) and IT.
  • management of relationship with key commercial partners.
  • compliance and maintenance of ISO13485 certification and management of all internal and/or external, regulatory and notified body audits.
  • maintenance of all IT physical assets and infrastructure.
  • grant applications, related compliance and reporting activities.

We measure your success in the role by your ability to complete your assigned KPI and responsibilities within the allocated timeline.

If you desire to work with a company that makes a difference to patient outcomes and are looking to join a friendly, progressive company, please apply below with a cover letter describing your achievements.

We recognise the value of diversity in our workplace and strive to promote fairness and equal employment opportunity.

 

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