Global Regulatory Affairs & Submissions Specialist

Atrium Medical; Hudson (NH); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

Atrium Medical Corporation is seeking a Regulatory Affairs professional to manage domestic and international submissions, under the direction of the Regulatory Affairs Director. You will prepare documentation for PMAs, 510(k)s, and IDEs, review labeling, and coordinate regulatory strategies across departments.

The role requires a Bachelor's degree in a scientific or engineering field and at least three years in regulatory affairs.

Competenze

• Bachelor's Degree in Scientific/Engineering discipline.
• 3+ years experience in regulatory environment.
• Ability to manage multiple projects in a fast-paced setting.
• Experience in domestic (510(k)/IDE/PMA) and international submissions/registrations.

Mansioni

• Prepare worldwide regulatory submissions/registrations.
• Assist Regulatory Affairs Director with regulatory strategy/plans.
• Review labeling, promotional materials, and product modifications.
• Coordinate FDA/ISO/CMDR compliance documentation.
• Support cross-functional product development activities/meetings.

Conoscenze

Regulatory affairs

FDA submissions

510(k)

PMA

IDE

QSR

Labeling review

Cross-functional teamwork

Documentation

Formazione

Bachelor's degree in science/engineering

Descrizione del lavoro

Atrium Medical Corporation is seeking a Regulatory Affairs professional to manage domestic and international submissions, under the direction of the Regulatory Affairs Director. You will prepare documentation for PMAs, 510(k)s, and IDEs, review labeling, and coordinate regulatory strategies across departments.

The role requires a Bachelor's degree in a scientific or engineering field and at least three years in regulatory affairs.