Senior Medical Devices Regulatory Affairs Strategist

Biopharma Asia; Chester (Delaware County); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist in West Chester, PA. The role coordinates, compiles, and submits regulatory submissions for medical devices, ensuring compliance with federal, state, and local regulations.

Responsibilities include preparing registration documents, maintaining regulatory databases, and developing submission strategies. Requires 4–6 years of experience and a bachelor's degree; RAC is preferred.

Qualifications

• University bachelor’s degree or equivalent.
• Generally 4–6 years’ work experience.
• RAC certification for Medical Devices preferred.

Responsibilities

• Coordinate and submit regulatory applications to authorities.
• Review labeling, packaging, and labeling changes for compliance.
• Develop regulatory strategies and plans for product lifecycle.
• Interface with product development to gather submission information.
• Maintain regulatory databases and document controls.
• Ensure company compliance with applicable laws and internal policies.

Skills

Regulatory affairs

Medical devices

Communication

Analytical reasoning

Education

Bachelor's degree

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist in West Chester, PA. The role coordinates, compiles, and submits regulatory submissions for medical devices, ensuring compliance with federal, state, and local regulations.

Responsibilities include preparing registration documents, maintaining regulatory databases, and developing submission strategies. Requires 4–6 years of experience and a bachelor's degree; RAC is preferred.