Senior Regulatory Affairs Strategist, Global Medical Devices

Medline Industries, LP; Eagan (MN); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Regulatory Specialist Principal to develop strategic regulatory plans for global approvals and to guide products from conception through market entry and lifecycle management.

You will independently resolve regulatory issues, steer large-scale projects, and lead expert groups across diverse regulatory areas, including interactions with FDA and notified bodies.

Qualifications

• Education: B.A. or B.S. in life science, engineering, regulatory science, or related field.
• 5+ years of diverse global regulatory experience in the medical device industry.
• Ability to lead technical efforts in risk management and design development.
• Extensive experience authoring and submitting 510(k)s and CE Technical Files.
• Proven experience communicating with FDA and notified bodies.

Responsibilities

• Determine requirements for product submissions and regulatory filings for clearance/approval in assigned markets.
• Identify factors that could impact new product launches and propose solutions.
• Monitor regulation changes and update procedures, products or records accordingly.
• Lead internal groups and coordinate with external groups to complete regulatory filings.
• Lead communication with regulators to respond to non-conformances and questions.
• Lead labeling and claims development for multiple markets and projects.
• Manage complex regulatory projects with defined timelines and cross-functional teams.
• Proactively improve regulatory-driven processes and maintain compliance databases.

Skills

Regulatory strategy development

Global regulatory experience

Regulatory submissions (510(k))

FDA communications

Education

Bachelor's degree in life sciences / engineering / regulatory science

Job description

Medline Industries, LP seeks a Regulatory Specialist Principal to develop strategic regulatory plans for global approvals and to guide products from conception through market entry and lifecycle management.

You will independently resolve regulatory issues, steer large-scale projects, and lead expert groups across diverse regulatory areas, including interactions with FDA and notified bodies.