Regulatory Affairs Specialist

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Description
Main Accountabilities:

• Conduct research on regulatory changes & developments, regulatory submission requirements, and regultory processes,
• Assist in the development and review of procedures,
• Advise responsible personnel on regulatory requirements, develop options with recommendations, develop product regulatory strategies, and continuously assess project outputs & impacts on the regulatory strategy (including launch date),
• Validate product labels, instructions for use, advertising and promotional materials,
• Compile/organize content of regulatory applications & files, assess acceptability & completeness of documents, identify unmet needs & provide feedback, and ensure timely submissions,
• Interact with regulatory authorities & execute regulatory processes, provide feedback on application review progress (including questions), coordinate & review answers to questions, and report on submission issues

Studies and Experience:

• Bachelor's Degree required,
• Knowledge of regulatory requirements, guidance documents, and processes (local/global) with more than 5 years of practice in the field of IVD/MD in an international environment,
• Basic knowledge of QMS requirements (QSR and ISO 13485 and/or local GMP if appropriate) with developed knowledge of design & change control processes,
• Familiar with product profiles & technology, with company organization, and processes,
• Familiar with regulatory agency organization (e.g. US FDA, EU Notified Bodies, and China NMPA),
• Participation in local professional & trade organizations.

Skills and Qualifications:

• Analyze/understand regulatory requirements & identify solutions, and provide directions for proper implementation,
• Routine problem solving,
• Develop regulatory rationales, and justify the reasoning,
• Ability to communicate to internal stakeholders & regulatory agencies or their representatives,
• Work in an international environment.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).