Senior Regulatory Affairs Specialist – Wound Closure, Healing

Job not on LinkedIn

🔥 6 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• Provide regulatory guidance to project teams for strategic planning and submissions supporting Ethicon Wound Closure & Healing products • Develop and execute global regulatory strategies for new, modified, and marketed medical devices • Prepare regulatory documentation for submissions to health authorities, including European Notified Body, BSI, European MDR, and FDA • Ensure compliance with regulatory agency regulations and interpretations • Prepare responses to regulatory agency questions and correspondence • Gather and assemble submission information according to regulations and guidelines • Research and collect data and respond to regulatory agency and distributor requests • Advise on regulatory labeling requirements and review product labeling for compliance • Provide regulatory guidance to project teams and respond to product information requests • Support internal and external audits and help develop Regulatory Affairs best practices • Represent Regulatory Affairs on cross-functional project teams • Evaluate regulatory impacts on products and contribute to regulatory strategies and lifecycle management • Support complex projects, prioritize deliverables, and solve regulatory problems • Collaborate across functions and levels to advance regulatory objectives • Improve and simplify Regulatory Affairs processes while maintaining controls and compliance

🎯 Requirements

• Minimum of a Bachelor’s Degree from an accredited college or university is required • At least 4+ years of regulatory affairs or related/equivalent experience is required; 2+ years with an Advanced Degree • Experience with healthcare products and industry regulations is required • Knowledge of US and OUS health products regulations is preferred • Previous medical device submission experience is preferred • Ability to work independently and in a team environment • Ability to communicate clearly and accurately, verbally and in writing, to a widely varied audience • Ability to work well under deadlines • Excellent written and communication skills; fluency in English • Good judgment, decision-making, and problem-solving ability • Ability to work under own initiative and as a team player • Remote work in the United States for the right candidate, with up to 10% travel required

🏖️ Benefits

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington • Holiday pay, including Floating Holidays – 13 days per calendar year • Work, Personal and Family Time – up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year • Up to 10% travel