Senior Regulatory Strategy Lead - MedTech Surgery (Remote)

Johnson & Johnson MedTech; United States; On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental leave

Job summary

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to guide regulatory strategy for the OTTAVA robotics instrument and accessory portfolio. You will partner with engineering, clinical, and quality teams to drive submissions and approvals across the US and international markets.

The role requires strong experience in medical device regulatory submissions, health authority interactions, and a track record of delivering regulatory milestones on complex products.

Qualifications

• Bachelor's degree in Science, Engineering or related field.
• Advanced degree is highly desired.
• Experience with medical device regulatory submissions is required.
• Proven track record in developing and implementing regulatory strategies.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Collaborate with engineering and clinical teams across product development stages.
• Prepare and file FDA submissions (Q-submissions, IDEs, De Novo, 510(k)) and global health authority documents.
• Engage with health authorities and other stakeholders to support registrations and approvals.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Regulatory communications

Education

Bachelor's Degree in Science/Engineering

Advanced Degree preferred

Job description

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to guide regulatory strategy for the OTTAVA robotics instrument and accessory portfolio. You will partner with engineering, clinical, and quality teams to drive submissions and approvals across the US and international markets.

The role requires strong experience in medical device regulatory submissions, health authority interactions, and a track record of delivering regulatory milestones on complex products.