Senior Regulatory Affairs Specialist

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The Senior Regulatory Affairs Specialist is a hands-on individual contributor who partners closely with cross-functional teams to deliver regulatory strategy and execution for products within the Interventional Oncology business. This role requires strong regulatory judgment, comfort navigating ambiguity, and the ability to translate evolving regulatory requirements into clear, actionable guidance.

Under the direction of Regulatory Affairs Management, the Senior RA Specialist independently owns regulatory assessments, develops regulatory strategy options, and partners with senior leadership on final regulatory decisions. This role is well-suited for a regulatory professional who thrives in fast-paced NPI environments and brings both execution excellence and sound decision-making

This role combines knowledge of scientific, regulatory, and business issues to ensure that products are developed, manufactured, and distributed in compliance with global regulatory requirements. Under the direction of Regulatory Affairs Management, the Senior Regulatory Affairs Specialist acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and provides critical regulatory support for new product development. This is an on-site role/hybrid in the Austin TX/Shoreview MN office with less than 20% travel requirements

Key Responsibilities

• Serve as a regulatory partner to R&D, Quality, Clinical, Manufacturing, Operations, and Marketing teams across NPI and sustaining activities.
• Independently assess regulatory impact for new products and changes, and provide clear regulatory pathway recommendations.
• Develop and maintain regulatory strategies aligned with business priorities and evolving regulatory requirements.
• Interpret and apply applicable regulations, standards, and guidance (e.g., FDA, EU MDR, Health Canada and ROW) and translate them into practical development guidance.
• Review and approve R&D, quality, preclinical, and clinical documentation for regulatory submissions.
• Compile, prepare, review, and submit high-quality regulatory submissions in the U.S., EU, and Canada; support international filings as needed.
• Support regulatory authority interactions by drafting briefing materials, responses, and correspondence.
• Prepare and maintain licenses, registrations, and listings for assigned geographies.
• Support product safety reporting (e.g., MDR, Vigilance), recalls, audits, and regulatory inspections.
• Maintain regulatory files, systems, and tracking databases.
• Identify emerging regulatory issues and proactively provide guidance to functional teams.
• Exercise sound, ethical judgment in compliance with regulations and company policy.
• Manage multiple priorities concurrently with accuracy and accountability.

Decision-Making & Operating Model

• Owns regulatory assessments and change impact determinations.
• Develops regulatory pathway options and brings clear recommendations.
• Identifies emerging regulatory risks, gaps, and opportunities and proactively bringing forward strategic recommendations.
• Translates regulatory requirements in terms of risk, timeline, cost and business impact
• Partners with Regulatory Affairs Management on final regulatory decisions.
• Supports regulatory authority interactions through preparation and documentation.

Qualifications

Regulatory Role Specific:

• 7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices
• Demonstrated experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers.
• Experience in the use of clinical data to support regulatory submissions (e.g. expansion of indications)
• Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus.
• Strong ability to interpret regulations, identify regulatory data needs, and solve regulatory issues.
• Ability to balance detailed execution with broader regulatory strategy development.
• Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.

Nice to have: