Senior Regulatory Affairs Program Lead – Wound Closure, Healing

Job not on LinkedIn

🔥 26 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $109k - $174.8k / 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

• Own end-to-end lifecycle maintenance and new product development launches for the Wound Closure and Healing portfolio • Provide independent regulatory guidance for strategic planning, pre-marketing, and regulatory submissions • Lead submissions of licenses, authorizations, international registrations, and dossiers for medical devices • Represent Regulatory Affairs on cross-functional teams and serve as a regulatory subject matter expert • Define and obtain data supporting regulatory submissions, including clinical data • Guide New Product Development and Lifecycle Change Management projects • Prepare expert responses to regulatory agency questions and correspondence • Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s • Prepare and submit EU MDR submissions • Collaborate on labeling and claims development and approval • Provide Regulatory Affairs support during internal and external audits • Plan regulatory deliverable schedules and monitor projects through completion • Develop Regulatory Affairs process best practices and solve complex problems • Apply expert knowledge of relevant guidances, regulations, and standards • Identify and resolve regulatory challenges and engage internal and external stakeholders • Promote continuous learning, cross-functional collaboration, and effective communication

🎯 Requirements

• Minimum of a Bachelor's Degree from an accredited college or university is required • At least 6+ years of regulatory affairs or related/equivalent experience is required; 4+ years with an Advanced Degree • Experience in the healthcare products industry, including submissions, is required • Experience with clinical development strongly preferred • Previous medical device submission experience for medium- and high-risk devices preferred • Demonstrated track record of leadership success strongly preferred • Experience leading multifunctional teams preferred • Previous experience with combination products preferred • RAC (Regulatory Affairs Certification) is desirable • Experience working and negotiating with regulatory bodies is desirable • Ability to work independently and in a team environment to solve problems and identify process gaps • Ability to communicate clearly and accurately, verbally and in writing, to varied audiences • Ability to work well under deadlines • Excellent written and communication skills; fluency in English • Good judgment, decision-making, and problem-solving ability • Motivated self-starter able to work independently and as a team player • Remote candidate must be able to accommodate up to 20% travel

🏖️ Benefits

• Fully remote work options considered on a case-by-case basis • 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 • Up to 20% travel