Regulatory Scientist - Software Development

Are you are Scientist or Engineer passionate about strategic regulatory guidance? Do you seek opportunity to work in new product development, lead regulatory submission process, and throughout product lifecycle? If so, a Regulatory Scientist role is calling for you.
Global Regulatory Affairs leads the creation of regulatory strategy that expedites product development, improves the probability of success and mitigates risks. Scientists exercise considerable judgment in determining approach and then researches, prepares, and submits required regulatory documentation including those in response to inquiries during the regulatory review process. Daily utilization of regulations, guidelines, and regulatory precedence to expedite the development and delivery of safe and effective products to improve the patient experience is integral to the role.
This position will support products in digital health, which may include software as a medical device (SaMD), mobile medical apps and/or embedded software (SiMD) as part of electromechanical devices. You will work in a collaborative team across multiple functions to integrate a successful regulatory strategy; developing and maintaining effective and mutually positive relationships across Lilly businesses, functions, partner companies, and with the FDA. Every single day you will....

• Demonstrate knowledge from FDA meetings and regulatory trends to define the regulatory strategy and associated submission strategy.
• Provide regulatory expertise to identify, prevent, and solve complex regulatory issues for product development.
• Understand and communicate the benefits and risks of the product and ensures addressed in risk assessments.
• Translate business unit needs / patient needs into product requirements and defined specifications.
• Communicate and negotiate effectively with FDA and internal customers to ensure clear understanding and expectations of the strategy.
• Provide high quality, timely, and critical regulatory advice to ensure well-informed decisions are made on new product development or lifecycle planning.

Your ability to influence the early lifecycle development, apply lessons learned, from other product development and competitor knowledge is crucial. In this role you should be able to....

• Work effectively with internal and external organizations to assess regulations for potential new products and influence the development work to meet regulatory expectations.
• Negotiate and influences regulators such as FDA (CDRH, OCP, DMEPA, etc).
• Build, maintain, and leverage relationships with customers (particularly with FDA), team members, and partner companies as appropriate.

Company Overview

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 39,000 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 people around the world.

Basic Qualifications

• Bachelors Science, Engineering or Equivalent with 7-10 years of increasing responsibility in medical device product development, 3-5 years of which include experience in development of software as or in medical devices.
• 1-2 years with FDA interactions &/or submissions

Additional Information

• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Additional Skills/Preferences

• Extensive experience with preparing strategies and conducting FDA interactions and successfully securing a number of FDA clearances and/or approvals (510(k), IDE, PMA).
• Knowledge and experience with connected medical devices. Experience with firmware & software development, system controls, cybersecurity, wireless and/or handheld device application development and familiarly with engineering technologies, and requirements.
• Knowledge &/or experience of Regulatory roles with responsibility with software as or in medical device products.
• Application of risk assessments, analysis, building FMEAs, FTA, and Safety Assurance Cases.
• Experience in software &/or computer systems design standards and verification and validation.
• Designing & developing consumer medical devices / home health solutions, including Human Factors requirements and testing.
• Advanced degree, degree in Computer Engineering or Science, Electrical Engineering, RAC certificate
• Knowledge of Good Clinical Practices (GCP) regulations and/or experience with clinical trial applications, IRBs, protocols, execution, and/or report summaries.
• Proven learning agility, strong level of curiosity and willingness to learn
• Demonstrated ability to organize key messages and connect rationale that supports or highlight risks of gaps in written, spoken, and presentation communication skills.
• Demonstrated negotiation and influence skills.