Manager, Regulatory Affairs

The Regulatory Affairs (RA) Manager manages the day-to-day operations of the RA Team to ensure effective regulatory submissions, timely regulatory approvals, application of regulatory requirements for the design and development of all product lines, and development of best practices for RA processes for pre- and post-market submissions.

• Manage team workload, accountability, timelines, remove roadblocks, and foster and maintain a workplace culture respectful and supportive of individual differences
• Communicates directly with leadership on proposed improvements
• Manage regulatory submissions
• Actively pursue ways in which to improve the function of the Regulatory Affairs department
• Communicate directly with regulatory agencies and distributors
• Help refine and implement Regulatory practices/procedures
• Effectively communicate with cross-functional leadership
• Responsible for performance reviews
• Demonstrated ability to provide consistent leadership in a team setting
• Demonstrated ability to manage conflict, communication & resources across multiple projects
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Implement policies, programs and directives of senior management
• Make recommendations for staff and equipment and have significant input into personnel matters
• Other duties as assigned

• Bachelor’s degree in life science, biology or related field; or experience of such kind and amount as to provide a comparable background
• 6+ years relevant regulatory experience, previous leadership experience preferred.
• Experience with FDA in Medical Device field
• Completion of RAC and MDR experience preferred
• Demonstrated scientific and/or medical writing experience preferred
• Experience in the preparation of clinical trial documentation preferred
• ISO Auditor training (MDD, MDR, MDSAP) preferred
• Familiarity with domestic and international regulatory requirements

Physical Requirements/Work Environment:

• Requires occasional early morning or evening teleconferences
• Occasional travel, domestic & international, may be required.
• Works remotely an/or under general office environmental conditions
• Sits for extended periods, utilizes close visual acuity for working with computers, etc.
• Must be able to perform the essential functions of the job, with or without reasonable accommodations.
• Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.