Senior Regulatory Affairs Specialist

🔥 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

This company has sponsored H1B visas in the past.

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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

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

🎯 Requirements

• Minimum of a Bachelor's Degree required; advanced degree highly desired • 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 and ability to lead multiple projects/tasks simultaneously and prioritize effectively • Strong learning skills for complex technology • Presentation skills to present complex regulatory strategies clearly, concisely, and comprehensively • Previous experience with health authority meetings/interactions preferred • Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and submission documentation preferred

🏖️ Benefits

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours • 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 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 25% travel opportunity/requirement • Inclusive interview process and disability accommodations