Senior Regulatory Affairs Specialist

🕒 June 18

🇺🇸 United States – Remote

💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 30%

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.

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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 • Determine requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned markets • Identify factors that could impact new product launches in assigned markets • Monitor regulatory changes affecting current or future requirements and compliance • Communicate regulatory requirements to internal and external customers • Recommend regulatory pathways, strategies, and solutions for specific products and scenarios • Review and direct supporting evidence to ensure it meets regulatory requirements • Assess records against regulations, guidance documents, and standards • Complete and maintain regulatory filings by leading internal groups and collaborating with external groups • Evaluate and direct supporting technical information and write summary documentation • Provide direction on product/project changes and respond to regulator non-conformances and questions • Participate in developing, reviewing, and substantiating product labeling and claims • Manage projects by defining task and team timelines and recommending future actions and solutions • Assist in reviewing and developing regulatory processes • Assist in maintaining department databases, logs, and files for ongoing compliance • Participate in internal and external audits when applicable

🎯 Requirements

• B.A. or B.S. degree in a life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related field • At least 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 • Ability to travel up to 10%

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Access to the Employee Assistance Program (for employees working less than 30 hours per week) • Employee Resource Groups (for employees working less than 30 hours per week) • Employee Service Corp (for employees working less than 30 hours per week) • Bonus and/or incentive eligibility • Career growth opportunities • Diversity, inclusion, and belonging resources