Regulatory Affairs Specialist

A Regulatory Affairs Specialist is responsible for developing regulatory strategy and assessing risks for IVD, RUO, Veterinary, and Clinical Industry products, guiding them through government/regulatory approval. This role involves capturing worldwide regulatory requirements, preparing FDA and EU submissions, and communicating with Health Authorities. Key duties include maintaining regulatory documentation, participating in submissions, staying current with regulations, assessing change requests, and advising project teams on premarket and compliance issues, ensuring global product registration tracking and quality compliance.

Must Have

• Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
• Participate in the preparation of regulatory submissions (US, EU, Global) and additional information or responses as requested by regulatory agencies.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Perform interpretation of regulatory rules or rule changes and ensure their proper communication through corporate policies and procedures.
• Perform assessment of change requests (device/labeling), with minimal oversight.
• Write or update standard operating procedures and work instructions.
• Ensure accurate population of databases for tracking global product registrations.
• Perform all work in compliance with company quality procedures and standards.
• Bachelor degree required.
• 2+ years of regulatory affairs experience.

Good to Have

• Science background is preferred.
• Medical device/IVD industry preferred.
• Knowledge of MD/IVD requirements or equivalent preferred.

Position Summary

A member of the RA team is responsible for developing regulatory strategy and assessing regulatory risks for products (for both registration and change), driving IVD (as well as RUO, Veterinary, and/or Clinical Industry) products through government/regulatory approval processes. Capture and communicate worldwide regulatory requirements for product development, global product registrations, and / or life cycle management. Preparation of FDA and EU submission files and communication with Health Authorities to ensure regulatory approval. This position may require support from more senior RA members/RA managers.

Primary Duties

• Organize, updating, and maintain regulatory documentation in accordance with company policy and procedures.
• Participate in the preparation of regulatory submissions (US, EU, Global) and additional information or responses as requested by regulatory agencies.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Perform interpretation of regulatory rules or rule changes and ensure their proper communication through corporate policies and procedures.
• Perform assessment of change requests (device/labeling), with minimal oversight.
• Write or update standard operating procedures and work instructions.
• Begin to advise project teams on subjects such as premarket requirements, registration requirements, compliance issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager.
• May begin to mentor or train more junior regulatory personnel/trainee, where applicable.
• Can be given tasks with relatively little oversight and trusted to complete them appropriately.
• Can lead meetings and guide discussions regarding regulatory topics.
• Can be assigned projects to lead on their own with some guidance from senior regulatory employees/managers.
• Ensures accurate population of databases for tracking global product registrations.
• Perform all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

Qualifications

Education and Training

• Bachelor degree required
• Science background is preferred

Experience

• 2+ years of regulatory affairs experience
• Medical device/IVD industry preferred

Knowledge, Skills, and Abilities (KSAs)

• Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy
• Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment
• Leading without authority through influence and guidance of others towards a common goal by using expertise, persuasion, and personal qualities to inspire action
• Technical learning aptitude to quickly understand and acquire new technical knowledge and skills
• Knowledge of MD/IVD requirements or equivalent preferred
• Learning agility to be able to learn from experiences and apply that knowledge to new situations
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace
• Detail orientation to complete tasks without errors and produce high-quality work
• Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time
• Effectively deal with ambiguity requiring adaptability, critical thinking, and proactive communication to navigate situations with limited details
• Perspective to see the world from another person's viewpoint thus gaining new insights and finding creative solutions to challenges
• Influence change using skills and relationships to persuade others to adopt new ideas, behaviors, or processes
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• Informing others by sharing clear, timely information to ensure alignment
• Troubleshooting issues to identify and resolve problems efficiently
• Driving continuous improvement by evaluating processes and implementing necessary changes
• Demonstrates assertiveness and confidence in the face of a challenge
• Solution oriented in the face of conflict
• Ability to deal with difficult situations in a timely and bold manner
• Make a stand in the presence of opposition
• Action Oriented: Takes action even when facing challenges
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Ability to cooperate with others at all levels including leadership
• Effective Presentation Skills - including the ability to present technical data
• Written Communications - including the ability to communicate technical data in written form
• Effective verbal communication skills
• Build and maintain positive, productive interactions with colleagues
• Fosters a culture of inclusiveness among all team members
• Ability to work well within a global team environment
• Emotional intelligence by having the ability to recognize, understand, and manage one's own emotions, as well as the emotions of others
• Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes
• Maintain composure by having the skill of staying calm, focused, and professional in high-pressure or stressful situations

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).