Senior Regulatory Affairs Specialist

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

📋 Description

• Accountable for the planning and execution of global regulatory initiatives essential for securing and maintaining worldwide regulatory approvals.

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

• Identify elements that may influence the success or feasibility of new product introductions in designated market(s).

• Stay informed about regulatory changes that affect current or future requirements and overall compliance.

• Convey regulatory requirements to both internal and external stakeholders.

• Review and guide to ensure that supporting documentation adheres to relevant regulatory standards.

• Oversee and sustain various regulatory submissions by leading internal teams and collaborating with external partners.

• Manage individual projects by directing diverse regulatory pathways.

• Assist in the evaluation and creation of processes related to regulatory functions.

⛳️ Requirements

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

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

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

• Experience in preparing responses and engaging with regulatory agencies.

• Knowledge of the current regulatory landscape and the ability to operate effectively within it.

• Practical understanding of FDA regulations and guidelines.

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

🏝️ Benefits

• Health insurance

• Life and disability insurance

• 401(k) contributions

• Paid time off