Senior Regulatory Affairs Lead, Wound Closure Healing Remote

Biopharma Careers; Raritan (NJ); Hybride; USD 150 000 - 190 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive lifecycle management and new product launches in the Wound Closure and Healing portfolio. You will guide regulatory strategy, Collaborate with development teams, and manage submissions for US/EU market access.

The ideal candidate has 6+ years in regulatory affairs for healthcare products, with strong communication skills and a proven leadership record. This role offers hybrid work options near Raritan, NJ.

Qualifications

• Experience guiding regulatory strategy for medical devices or combination products.
• Strong track record in FDA submissions (Q submissions, IDEs, De Novo, 510(k)).
• Ability to lead cross-functional teams and regulatory audits.

Responsabilités

• Represent Regulatory Affairs on cross-functional teams and serve as regulatory SME.
• Provide regulatory strategy input during NPD and Lifecycle Change projects.
• Prepare responses to regulatory questions and agency correspondence.
• Prepare and submit FDA and EU regulatory information for market access.
• Lead license and international registration submissions for ongoing products.
• Collaborate on labeling and claims development and support audits.

Connaissances

Regulatory strategy

FDA submissions

Cross-functional leadership

Regulatory affairs

English communication

Formation

Bachelor's degree in a relevant field

Advanced degree preferred

Description du poste

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive lifecycle management and new product launches in the Wound Closure and Healing portfolio. You will guide regulatory strategy, Collaborate with development teams, and manage submissions for US/EU market access.

The ideal candidate has 6+ years in regulatory affairs for healthcare products, with strong communication skills and a proven leadership record. This role offers hybrid work options near Raritan, NJ.