Independently leads planning, preparation, review, and submission of regulatory dossiers for medical device products and lifecycle changes. Coordinate submission strategies and timelines across internal stakeholders to support global market access.
Demonstrates a deep understanding of medical device regulatory requirements, including global submission pathways, applicable standards, and lifecycle expectations, and applies this knowledge to ensure compliant, high-quality submission strategy and execution.
Acts as primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverable
Compile, review, and publish high-quality submission documents, including technical files, variation packages, amendments, and responses to health authority questions, ensuring all submissions are accurate, complete, and compliant with applicable regulations, standards, and company procedures.
Manage preparation of submission structures, Track submission status, identify risks, and escalate issues that may impact timelines or approval outcomes.
Maintain awareness of evolving regulations, guidance, and submission requirements for relevant markets.
Maintain submission trackers, regulatory databases, and document control systems.
Collaborate with cross-functional teams to gather technical, quality, clinical, and labeling information needed for submissions.
Identify gaps and contribute to process improvement initiatives and best practices for submission management to enhance submission efficiency, quality, and compliance.
Requirements
Bachelor's degree in scientific, regulatory, or related discipline.
6+ years of experience in regulatory affairs, quality, or clinical
Experience within the medical device industry.
Experience preparing and managing regulatory submissions for medical devices in one or more regions, such as FDA, EU MDR/IVDR, or other international markets.
Strong understanding of medical device regulatory requirements, process and documentation practices, submission formats, and product lifecycle processes.
Advanced degree, PMP and RAC certification is a plus.
Experience with FDA, EU MDR, PMA, 510(k), De Novo, technical documentation, or international device registrations.
Other Required Skills:
Excellent project management, organizational, and communication skills.
Ability to work cross-functionally and manage multiple priorities under tight timelines.
Detail-oriented with strong analytical and problem-solving abilities.
Strong attention to detail and problem-solving abilities.
Ability to influence without authority and coordinate across global teams.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
The Device Regulatory Affairs Submission Manager is responsible for leading the planning, preparation, coordination, and submission of regulatory dossiers for medical devices and combination products throughout the product lifecycle. This experienced professional partners with Regulatory Affairs leadership and cross-functional teams to drive submission execution, ensure high-quality deliverables, and maintain compliance with applicable regulatory requirements and company procedures. The role requires deep knowledge of device submission processes, strong project management skills, and the ability to train and mentor junior staff. This position ensures submissions are accurate, complete, compliant with global regulatory requirements, and delivered on time to support product development, approvals, lifecycle maintenance, and post-market activities. The role also requires close collaboration with teams in R&D, Quality, Clinical, Manufacturing, and external publishing vendors.
Abbvie · North Chicago, IL