Work Flexibility: Hybrid or Onsite

This is a Hybrid role (2 days onsite) and can be located in Cork or Limerick​

What you will do:

Provide support and direction to scientists and engineers in the field of Biocompatibility and Toxicology.Partner with cross-functional project teams to define evaluation/verification strategies of medical devices.Identify new/emerging regulatory requirements and customer needs and develop strategies that enable business to react in a compliant and efficient manner.Proactively identify risks and deficiencies in product designs and manufacturing processes/supply chain and collaborate with the business to drive mitigation strategies.Lead projects to increase capabilities that enable cost savings, speed to market, and efficient use of resources.Interpret, assess, analyze, and apply international standards (i.e. cleaning, disinfection, and biocompatibility) to drive best-in-class processes.Lead the development or revision of quality system procedures. This may include serving as a divisional and/or corporate process owner.Support Business Development/Acquisition reviews as an SME.Assess new/game changing technologies for use within/across businesses and product lines.Support internal and external regulatory audits as an SME.Lead interactions with FDA or Competent Authorities.Lead responses to internal and external customer inquiries.Mentor and coach internal talent to increase technical competencies.Lead and participate in Corporate wide projects or initiatives.Partner with internal/external labs to support biological safety testing.Represent the company on a scientific level at international meetings. This may involve presentation to regulatory authorities and/or writing scientific papers for publication.

Technical Skills:

Expert knowledge of the field of biocompatibility for medical devices and applicable standards and regulations (i.e. ISO 10993)Expertise and ability to lead teams in implementing FDA, GMP, ISO, and other medical device regulatory requirements.

What you will need:

Bachelor of Science required; in Science in Biology, Microbiology, Chemistry, or Biomedical Engineering, preferred.10+ years of work experience, required.Advanced degree preferred.Minimum 5 years experience leading teams

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Travel Percentage: None