Open Position

Senior Regulatory Manager

Burnsville, MN

Basic Function

The Senior Regulatory Manager is responsible for managing our medical device regulatory affairs and our regulatory team. This role manages the planning and execution of Imricor’s advanced regulatory strategies to support product development and lifecycle management, ensuring timely submissions and approvals in the US, EU, and international markets. The Senior Regulatory Manager also provides leadership to cross-functional teams ensuring continuous improvement in regulatory processes and systems in alignment with Imricor’s Quality Management System and environmental, health, and safety policies.

Location: Must be able to work in the Burnsville, MN office

Compensation: The expected annual base salary range for this Minnesota-based position is $140,000-190,000. This range represents a good faith estimate and may vary based on the candidate’s experience, skills, and qualifications. This role may also be eligible for a comprehensive benefits package, including Medical, Dental, Vision, Health Savings Accounts, FSAs, Disability, Life Insurance, and Retirement Benefits.

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Responsibilities

Manages the creation and execution of regulatory strategies for new product introductions, significant changes, and lifecycle management.
Oversees the interactions with regulatory bodies (e.g., FDA, EU Notified Bodies, and other global agencies), effectively managing complex submission interactions and negotiations.
Manages the authors and reviews high-quality regulatory submissions, including PMAs, 510(k)s, IDEs, CE Technical Files under EU MDR, and global registrations.
Supports the Regulatory team in interpreting and assessing the impact of product and manufacturing changes to ensure ongoing regulatory compliance across global markets.
Manages the creation and execution of labeling strategies across the product portfolio and ensures regulatory compliance for device labeling.
Provides management of the regulatory team members to ensure effective and efficient performance.
Manages Medical Device Reporting (MDRs), Vigilance Reporting, and field actions following applicable regulatory requirements.
Manages to ensure continuous improvement for regulatory processes, documentation quality, and compliance practices.
Oversees and communicates changes in global regulations and standards and proactively update stakeholders to ensure corporate readiness.
Performs other related duties and strategic initiatives as assigned.

Qualifications

Bachelor of Science in a scientific or engineering discipline; an advanced degree is strongly preferred.
10+ years experience in Regulatory Affairs within the medical device industry.
3+ years of management experience in Regulatory preferred.
Demonstrated expertise in global regulatory requirements, including FDA, EU MDR, and other international markets.
Demonstrated experience leading regulatory submissions and gaining approvals for Class II and III medical devices.
Strong interpersonal and communication skills with the ability to influence and collaborate across all levels of the organization.
Exceptional project management, problem-solving, and critical thinking skills.
Proficiency in Microsoft Office and regulatory documentation tools.