Staff RA Specialist - Data/IT

Description

As part of the Regulatory Affairs Team, we are in search of a RA Data IT Specialist who will act as Regulatory Affairs subject matter expert and support business activities.

Main Accountabilities:

• Support compliance of our systems and software with applicable regulations and standards applicable to Medical Devices, IVD Medical Devices, Software as Medical Device throughout the product lifecycle.
• Support the regulatory teams involved in the regulatory submissions for systems and software on the topics related to cybersecurity, AI/ML, EHDS, UDI among others.
• Assist in the development of answers to questions in the interactions/negotiations with regulatory authorities and stay current with regulatory knowledge.
• Perform a regulatory watch to identify new requirements applicable and perform related impact assessments.
• Assist in the execution and improvement of regulatory processes related to cybersecurity and AI/ML and interactions with internal/external stakeholders.
• Participate to external trade associations.
• Represent department in transversal company projects that require regulatory input and guidance.

Studies-Experience:

• Master's degree or equivalent in Science or Engineering preferred
• 8+ years in regulatory affairs and/or system engineering, or equivalent, medical device/IVD industry preferred.
• Expertise in system/software lifecycle development and in particular cybersecurity and AI/ML.
• Excellent verbal and written communication skills.
• Fluent communication in English.

Skills and Qualifications:

• Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory and quality environment.
• Strong communication skills, both written and verbal, is required.
• Ability to influence peers, higher leaders and external expert or regulatory agencies.
• Ability to analyze and use data to drive decisions; analyze and understand technical documents and regulatory requirements.
• Comprehensive knowledge of regulations and standards applicable to Medical Device/IVD Medical Device.
• Knowledge of preparation of dossiers; technical writing skills to develop clear conclusions based on design documentation and to compile dossiers.
• Routine problem solving, develop rationale, and propose solutions.
• Mobility: Travel as needed (external meetings with the local and corporate teams, trainings).

Job based in USA (Salt Lake City).

Working at bioMerieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 13 000 employees to blossom throughout their career, while respecting each employee's individual talents as well as their personal and professional development.

At bioMerieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

bioMerieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.