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Cork, CO, T23, IE
Job details
Work flexibility: Hybrid or Onsite
Req ID: R536089
Employee type: Full Time
Job category: RAQA
Travel:
Relocation: No
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Job description
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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