Senior Regulatory Affairs Specialist

Job not on LinkedIn

🔥 0 minutes ago

🏄 California, New Jersey, +1 more states – Remote

🏄 California – Remote 🏖️ New Jersey – Remote 🏈 Ohio – 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

• Support the Instrumentation & Accessories team under the OTTAVA robotics group • Help Robotics & Digital Solutions reach US and international regulatory new product development approval goals • Address regulatory affairs needs for robotics, instruments, and accessories portfolios • Work with engineering and clinical teams during product development stages • Generate submission-ready documentation and author regulatory submissions • Support health authority communications • Participate in regulatory strategy development • Implement regulatory strategies for new product clearances and approvals • Prepare, write, and file FDA submissions, including 510(k)s, and global health authority technical submissions • Identify issues, communicate project timelines, and address issues affecting registration status • Guide conformance with regulations and guidance documents for product development, claims, labeling, and promotional materials • Assist in developing Regulatory Affairs processes

🎯 Requirements

• Minimum of a Bachelor's Degree required; desired areas of study include Science, Engineering, or related field • Minimum of 4+ years of related Regulatory Affairs experience within Medical Device required; 3+ years with Advanced Degree • Experience with medical device regulatory new product submissions required • Demonstrated track record of developing and driving implementation of regulatory strategies • Working knowledge of how global regulations impact product registration • Good communication skills for effective collaboration with cross-functional partners • Ability to correspond and collaborate with J&J colleagues globally • Ability to evaluate new regulatory requirements and regulatory changes and assess business impact • Excellent verbal and written communication skills; strong attention to detail • High organization skills with ability to lead multiple projects/tasks and prioritize effectively • Strong learning skills for complex technology and presentation skills to present complex regulatory strategies clearly • Up to 25% travel required • Previous experience with health authority meetings/interactions preferred • Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements preferred

🏖️ Benefits

• Consolidated retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees • 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