Job Description
Scientist/Sr. Scientist/Principal Scientist (R1-3) role at Eli Lilly Cork requires expertise in device technical knowledge, regulatory, and device expertise to drive internal consistency and influence effective change management.
Eli Lilly Cork is a global healthcare leader with a diverse team of over 1,600 employees across 38 nationalities. The company offers a premium workspace with flexible hybrid working options, healthcare, pension, and life assurance benefits, as well as in-house people development services and wellbeing initiatives.
The company is committed to diversity, equity, and inclusion (DEI) with four pillars: EnAble, Age & Culture, LGBTQ+, and GIN-Gender Inclusion Network. EnAble partners with the Access Lilly initiative to make the physical and digital environment accessible and inclusive for all.
The role will support global registrations, product maintenance, and GRA-Devices; Drug Delivery, Digital Health, and Diagnostic department operations. The Scientist will utilize device technical knowledge, regulatory, and device expertise to drive internal consistency and influence effective change management.
Key Responsibilities:
- Provide regulatory guidance to product teams and/or affiliates while implementing regulatory strategies that result in successful global product registrations and device maintenance.
- Exhibit leadership behaviors and incorporate new regulations, guidance, and company positions into GRA-Device processes/guidelines, tools, and/or training materials.
- Support internal policy development and provide internal input on emerging regulations worldwide for device issues.
- Monitor global regulatory news and provide interpretation and internal communication as appropriate.
- Support interactions with global Health Authorities as required, including key ISO and notified body personnel.
Requirements:
- Bachelor's degree in a scientific or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline)
- Medical Device or Pharmaceutical industry experience in technical drug and/or device development (3-4 years)
- Prior experience authoring device submission content
- Prior regulatory experience (2-3 years) or equivalent combination of technical and regulatory guidance knowledge
- Demonstrated negotiation and influence skills
- Demonstrated strong written, spoken, and presentation communication skills
- Demonstrated attention to detail
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Additional Information:
- English Fluency