Senior Regulatory Affairs Specialist

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

📋 Description

• Strategizing and implementing critical and intricate global regulatory initiatives.

• Formulating detailed regulatory strategies for new devices, new market launches, and modifications of existing devices in the market.

• Creating solutions for complex regulatory challenges.

• Leading cross-functional teams on high-priority projects.

• Identifying requirements for product submissions and regulatory documentation.

• Keeping track of regulatory changes.

• Conveying regulatory requirements to clients.

• Advising on regulatory pathways, strategies, and solutions.

• Reviewing and guiding on supporting evidence.

• Completing and maintaining a variety of regulatory filings.

• Engaging in the development, review, and validation of product labeling and claims.

• Overseeing individual projects by offering guidance on regulatory pathways.

• Assisting in the evaluation and creation of processes linked to regulatory activities.

• Taking part in internal and external audits when necessary.

⛳️ Requirements

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

• Minimum of 4 years of experience in regulatory affairs within the medical device sector, supporting either domestic or international markets.

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

• Proven background in preparing responses and engaging with regulatory bodies.

• Comprehensive understanding of the current regulatory landscape.

• Practical knowledge of FDA regulations and guidelines.

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

🏝️ Benefits

• Health insurance.

• Life and disability insurance.

• 401(k) contributions.

• Paid time off.

• Employee Assistance Program.

• Employee Resource Groups.

• Employee Service Corp.