Principal Regulatory Affairs

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

📋 Description

• Formulate regulatory strategies for global product approvals, ensuring successful market introduction of new products and the maintenance of existing ones.

• Engage in negotiations with regulatory bodies and advise on future product development initiatives.

• Independently address regulatory challenges and provide guidance on large-scale projects.

• Assess requirements for product submissions and regulatory filings necessary for clearance or approval in designated markets.

• Identify and address factors that influence the success or feasibility of new product launches.

• Stay updated on regulatory changes and implement required compliance modifications.

• Acquire and leverage knowledge of harmonized standards.

• Communicate regulatory requirements effectively to both internal and external stakeholders.

• Propose regulatory pathways, strategies, solutions, and future course of action.

• Evaluate evidence to ensure compliance with regulations, guidance documents, and standards.

• Oversee regulatory filings and coordinate efforts among internal and external teams.

• Interact with regulators regarding non-conformities and inquiries.

• Direct the development, review, and substantiation of product labeling and claims.

• Manage complex projects, timelines, technical deliverables, and diverse teams.

• Enhance and create regulatory-driven and technical processes.

• Maintain compliance databases, logs, and documentation.

• Lead audits and oversee corrective actions post-audit.

⛳️ Requirements

• Bachelor of Arts or Bachelor of Science degree in a life science discipline (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or a related field.

• Over 5 years of varied regulatory experience in the medical device sector.

• Strong background in global regulatory practices supporting both pre- and post-market regulatory processes.

• Proven experience with independent regulatory submissions.

• Background in participating in regulatory intelligence initiatives.

• Experience in developing and executing regulatory strategies across multiple international markets.

• Capability to lead efforts concerning risk management and design and development activities.

• Extensive experience in authoring and submitting regulatory submissions, including 510(k)s and CE Technical Files.

• Significant experience in communicating and negotiating with regulatory agencies, such as the FDA and notified bodies.

• Ability to work autonomously and lead large-scale projects with a considerable business impact.

🏝️ Benefits

• Competitive total rewards package.

• Opportunities for continuing education and training.

• Health insurance coverage.

• Life and disability insurance plans.

• 401(k) contribution options.

• Paid time off benefits.

• Access to an Employee Assistance Program.

• Participation in Employee Resource Groups.

• Involvement in Employee Service Corp.

• Eligibility for bonuses and/or incentive programs.

• Opportunities for career advancement.