BioLegend (a division of Revvity, Inc, ) is seeking a Regulatory Affairs Supervisor to support new product development and regulatory submissions for IVD products. The candidate will be responsible to determine the appropriate regulatory strategy, collaborate in new product development, prepare regulatory submissions including 510(k) premarket notifications for US FDA and technical files/documentation for registration of products in European Union, United Kingdom, Canada and other international registrations as needed. The ideal candidate must be able to work independently, have a strong attention to detail and technical writing skills.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prepare US FDA 510(k) submissions and maintain establishment registration and device listing
• Creation and maintenance of Technical Files for EU or UK
• Assessment of significant changes to products for supplemental regulatory filing
• Support China and other international registrations
• Prepare and submit Drug Master Files
• Participate as a core team member in cross-functional design and development projects, providing regulatory strategy for IVD new product development including appropriate analytical and clinical performance requirements
• Review of labeling and promotional material for regulatory compliance
• Support post-market regulatory activities as applicable
• Review new regulations, standards and guidance, and perform impact assessment
• Strong interpersonal, teamwork, and organizational skills
• Participate in continuous improvement events such as kaizen events
• Supervise QA team
• Support and facilitate internal and external audits, including ISO 13485 and Notified Body conformity assessments
• Assist in developing and maintaining company SOPs for global regulatory compliance
• Perform other assigned duties, projects, or responsibilities as required

iACT Competencies

• innovate - Be better, keep improving, be more efficient, creative, and be in the forefront of development
• Aspire - Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
• Collaborate - Foster teamwork, common goals, selflessness, communication and mutual support
• Transform - Adapt, learn, re-invent and change for future development and growth

Minimum Qualifications - Education and Experience

• Bachelor's degree and 5+ years of experience in the IVD or medical device industry
• Strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, IVDR 2017/746, UK MDR, Canada SOR/98-282
• 510(k) submission experience
• EU Technical Files experience

Preferred Qualifications - Education and Experience

• Bachelor's degree in life sciences, chemistry, or engineering
• 4+ years of regulatory affairs or relevant experience
• RAC certification
• Drug Master File submission experience is a plus
• US, EU, Canada and/or China regulatory affairs experience
• Knowledge of regulations, guidance and standards
• Experience writing procedures
• Attention to detail
• Can work independently with minimal supervision
• Highly motivated, dependable and a team player
• Strong organizational, documentation, and communication skills, especially technical writing skills

The base salary range for this full-time position is $100,000-$125,000/year. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

Work Environment & Physical Demands - Office

While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.