Senior Regulatory Affairs Specialist

🔥 12 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Plan and execute critical and complex global regulatory projects to obtain and maintain global regulatory approvals • Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes • Develop solutions for complex regulatory issues and lead multifunctional teams in high-priority projects • Determine requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned markets • Identify factors impacting the success or viability of new product launches • Monitor regulatory changes affecting current or future requirements and compliance • Communicate regulatory requirements to internal or external customers • Recommend regulatory pathways, strategies, and solutions • Review and direct supporting evidence to meet regulatory requirements • Complete and maintain regulatory filings, including technical information, summary documentation, product/project changes, and regulator responses • Participate in development, review, and substantiation of product labeling and claims • Manage projects, timelines, project teams, and future actions • Assist with regulatory process development and review • Maintain department databases, logs, and files for ongoing compliance • Participate in internal and external audits

🎯 Requirements

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related field • 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets • Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files • Experience preparing responses and communicating with regulatory agencies • Understanding of the current Regulatory environment • Applied knowledge of FDA regulations and guidelines • Ability to evaluate information to determine compliance with standards, laws, and regulations • Position requires up to 10% travel

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Bonus and/or incentive eligibility • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program • Employee Resource Groups • Employee Service Corp.