Senior Regulatory Affairs Specialist – Wound Closure & Healing

Job not on LinkedIn

🔥 5 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• Provide regulatory guidance to project teams for strategic planning and submissions supporting Ethicon Wound Closure and Healing products • Develop and execute global regulatory strategies for new, modified, and marketed medical devices • Prepare regulatory documentation for submissions to regulatory health authorities, including European Notified Body, BSI, European MDR, and FDA • Guide compliance with regulations in product development, claims, labeling, and promotional materials • Define data and information needed for regulatory actions with cross-functional teams • 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 throughout development and lifecycle management • Contribute to effective regulatory strategies aligned with business objectives • Support complex projects and deliver project deliverables with discipline and accountability • Collaborate across functions and levels to advance regulatory objectives • Improve and simplify Regulatory Affairs processes while maintaining compliance controls

🎯 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 • Ability to work well under deadlines • Excellent written and communication skills • Fluency in English • Good judgment, decision-making, and problem-solving ability • Position preferred in Raritan, NJ, or remote in the United States for the right candidate • 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 • Remote work option considered on a case-by-case basis • Up to 10% travel