Senior Regulatory Affairs Specialist

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

📋 Description

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

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

• Create solutions for intricate regulatory challenges.

• Direct multifunctional teams on projects of high priority.

• Identify requirements for product submissions and regulatory documentation necessary for clearance or approval in designated markets.

• Recognize factors impacting the success or feasibility of new product launches.

• Track regulatory modifications influencing current or future compliance and requirements.

• Convey regulatory obligations to both internal and external stakeholders.

• Suggest regulatory pathways, strategies, and solutions.

• Examine supporting documentation for regulatory adherence.

• Evaluate records against applicable regulations, guidance documents, and standards.

• Complete and manage regulatory filings and submissions.

• Lead internal teams and collaborate with external partners.

• Assess and direct supportive technical data.

• Draft summary documentation and guide on product or project alterations.

• Address regulatory non-conformances and inquiries from regulators.

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

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

• Support the evolution and evaluation of regulatory processes.

• Maintain regulatory databases, logs, and files.

• Take part in internal and external audits.

⛳️ Requirements

• Bachelor’s degree in life sciences, engineering, medical technology, regulatory science, or a related discipline.

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

• Proficiency 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.

• Applied understanding of FDA regulations and guidelines.

• Capability to assess information for adherence to standards, laws, and regulations.

• Position may require up to 10% travel.

🏝️ Benefits

• Competitive total rewards package.

• Continuing education and training opportunities.

• Health insurance coverage.

• Life and disability insurance options.

• 401(k) contributions.

• Paid time off.

• Employee Assistance Program.

• Employee Resource Groups.

• Employee Service Corp.

• Eligibility for bonuses and/or incentives.

• Opportunities for career advancement.

• Resources for diversity, inclusion, and belonging.