Senior Regulatory Affairs Program Lead – Wound Closure & Healing, MedTech Surgery

Job not on LinkedIn

🔥 5 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

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

• 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 submissions supporting global product launches • Lead submissions for 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 • Guide regulatory strategy and supporting evidence, including clinical data, for product development and lifecycle change 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, and EU MDR submissions • Collaborate on labeling and claims development and approval • Support internal and external audits • Plan regulatory deliverables and monitor projects through completion • Develop Regulatory Affairs process best practices and solve complex problems • Apply expert knowledge of relevant guidances, regulations, and standards

🎯 Requirements

• Minimum of a Bachelors Degree from 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 healthcare products product industry including submissions is required • Science, biomedical engineering, medical/scientific writing, or public health administration field of study desired • 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 multi-functional 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 • Ability to communicate clearly and accurately 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 candidates must be able to travel up to 20%

🏖️ Benefits

• Company 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 residents; 56 hours for Washington residents • 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 options considered on a case-by-case basis • Up to 20% travel required for remote candidates