Senior Regulatory Affairs Program Lead – MedTech Surgery

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $125k - $201.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

🧘 Wellness

Pharmaceuticals • Biotechnology • Wellness

<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

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator. • Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. • Prepares and submits regulatory information required to obtain global market access. • Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s). • Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. • Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status. • Guide conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. • Assists in the development and enhancement of Regulatory Affairs processes.

🎯 Requirements

• Minimum of a Bachelor's Degree required • Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required • Experience with Class II medical device regulatory product submissions required • Previous experience with health authority meetings/interactions required • A demonstrated track record of developing and driving implementation of regulatory strategies. • Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML. • Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601). • Excellent communication skills for effective collaboration with cross-functional partners. • Strong attention to detail. • Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.

🏖️ Benefits

• Pension and savings plan (401(k)) • Vacation –120 hours per calendar year • Sick time - 40 hours per calendar year • Holiday pay, including Floating Holidays –13 days per calendar year • 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