Regulatory Scientist - Devices Drug Delivery, Digital Health and Diagnostics

at  Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelor’s degree in a scientific or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline)
• Other Requirements:
• 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

The purpose of the Scientist/Sr. Scientist/Principal Scientist (R1-3) role is to provide tactical, and operational direction and support to expediate device related (drug-device delivery systems, medical devices (firmware, hardware, stand alone and embedded software) or diagnostic) registrations, right to operate and maintenance of Lilly’s portfolio by interacting with teams, Affiliates, and regulators. This role will support global registrations, product maintenance, and GRA-Devices; Drug Delivery, Digital Health and Diagnostic department operations.
The Scientist utilizes device technical knowledge, regulatory and device expertise to drive internal consistency and influence effective change management.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.