Senior Regulatory Affairs Lead, Wound Closure (Remote)

Brighter Signals

United States

Remoto

USD 92.000 - 148.000

Tempo pieno

8 giorni fa

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Vantaggi offerti da questo lavoro

Vacation –120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Parental Leave – 480 hours within one

Descrizione del lavoro

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing products. You will develop global regulatory strategies, prepare submissions to FDA/European authorities, and guide labeling and claims compliance.

Remote options within the United States are considered for qualified candidates. The role requires a strong background in regulatory affairs, with 4+ years in healthcare regulatory environments, and the ability to work independently within

Competenze

Minimum of a Bachelor's Degree from accredited college or university is required; Advanced Degree strongly preferred.
Experience: 4+ years of regulatory affairs or related experience; healthcare products industry knowledge preferred.
Excellent written and communication skills; ability to work with diverse audiences.

Mansioni

Provides regulatory guidance to project teams and develops global regulatory strategies for medical devices.
Prepares regulatory submissions and documents for health authorities (FDA, European MDR, Notified Bodies).
Supports product labeling, claims, and promotional materials to ensure compliance.
Leads interactions with regulatory bodies and audits; participates in cross-functional teams.