Senior Regulatory Affairs Specialist

🔥 15 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 regulatory strategies for new devices, launch markets, and post-market device changes • Develop solutions to complex regulatory issues • Lead multifunctional teams on high-priority projects • Determine requirements for product submissions and regulatory filings for clearance or approval in assigned markets • Identify factors affecting new product launch success or viability • Monitor regulatory changes affecting current or future requirements and compliance • Communicate regulatory requirements to internal and external customers • Recommend regulatory pathways, strategies, and solutions • Review supporting evidence for regulatory compliance • Assess records against regulations, guidance documents, and standards • Complete and maintain regulatory filings and submissions • Lead internal groups and collaborate with external groups • Evaluate and direct supporting technical information • Write summary documentation and provide direction on product or project changes • Respond to regulatory non-conformances and regulator questions • Participate in product labeling and claims development, review, and substantiation • Manage projects, timelines, project teams, actions, and solutions • Assist with regulatory process development and review • Maintain regulatory databases, logs, and files • Participate in internal and external audits

🎯 Requirements

• B.A. or B.S. degree in life science, 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 for compliance with standards, laws, and regulations • Position requires up to 10% travel

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program • Employee Resource Groups • Employee Service Corp • Bonus and/or incentive eligibility • Career growth opportunities • Diversity, inclusion, and belonging resources