Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Strategize and implement critical and intricate global regulatory initiatives to secure and uphold global regulatory approvals.

• Formulate detailed regulatory strategies for new devices, emerging launch markets, and modifications to existing products.

• Create solutions for complex regulatory challenges and guide cross-functional teams on high-priority projects.

• Assess requirements for finalizing and sustaining product submissions and regulatory filings for clearance/approval in designated markets.

• Identify elements that influence the success or feasibility of new product introductions.

• Stay informed about regulatory changes that could impact current or future compliance and requirements.

• Convey regulatory requirements to both internal and external stakeholders.

• Suggest regulatory pathways, strategies, and solutions.

• Evaluate and direct supporting evidence to fulfill regulatory standards.

• Complete and manage regulatory filings, which include technical details, summary documents, product/project modifications, and responses to regulators.

• Engage in the development, evaluation, and validation of product labeling and claims.

• Oversee projects, timelines, project teams, and subsequent actions.

• Aid in the development and assessment of regulatory processes.

• Maintain departmental databases, logs, and files to ensure ongoing compliance.

• Take part in both internal and external audits.

⛳️ Requirements

• Bachelor's degree (B.A. or B.S.) in a life science discipline (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or a related field.

• Four years of experience in regulatory affairs within the medical device sector, supporting domestic or international markets.

• Proven experience in authoring and submitting regulatory documents, including 510(k)s and/or CE Technical Files.

• Familiarity with preparing responses and engaging with regulatory agencies.

• Strong understanding of the current regulatory landscape.

• Practical knowledge of FDA regulations and guidelines.

• Capacity to assess information to ensure compliance with standards, laws, and regulations.

• Role requires up to 10% travel.

🏝️ Benefits

• Competitive total rewards package.

• Opportunities for continuing education and training.

• Eligibility for bonuses and/or incentives.

• Health insurance coverage.

• Life and disability insurance options.

• 401(k) contributions.

• Paid time off.

• Employee Assistance Program.

• Employee Resource Groups.

• Employee Service Corp.