Senior Regulatory Affairs Specialist

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

📋 Description

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

• Formulate detailed regulatory strategies for new devices, market launches, and post-market modifications.

• Identify requirements for product submissions and regulatory documentation in designated markets.

• Recognize elements that influence the success or feasibility of new product launches.

• Track regulatory developments that impact requirements and compliance.

• Convey regulatory requirements to both internal and external stakeholders.

• Propose regulatory pathways, strategies, and solutions.

• Assess supporting documentation to ensure regulatory compliance.

• Complete and uphold regulatory submissions by leading internal teams and collaborating with external partners.

• Analyze technical data and prepare summary documentation.

• Provide guidance on product/project modifications and address inquiries from regulators and non-conformities.

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

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

• Assist in the development and review of regulatory processes.

• Maintain departmental databases, logs, and records.

• Take part in both internal and external audits.

⛳️ Requirements

• Bachelor of Arts or Bachelor of Science in life sciences, engineering, medical technology, regulatory science, or a related discipline.

• A minimum of 4 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.

• Experience in preparing responses and liaising with regulatory bodies.

• Familiarity with the current regulatory landscape.

• Practical knowledge of FDA regulations and guidelines.

• Capability to assess information for compliance with applicable standards, laws, and regulations.

• Willingness to travel up to 10% of the time.

🏝️ Benefits

• Competitive total rewards package.

• Opportunities for continuing education and training.

• Health insurance coverage.

• Life and disability insurance options.

• 401(k) contributions available.

• Paid time off.

• Access to the Employee Assistance Program.

• Participation in Employee Resource Groups.

• Access to Employee Service Corp.

• Opportunities for career advancement.