Regulatory Affairs Specialist

Position Summary

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

• Bachelor degree required
• Science background is preferred

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

• 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