Regulatory Affairs Specialist

Atrium Medical; Hudson (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

FDA submissions

510(k)

PMA

IDE

QSR

Labeling review

Cross-functional teamwork

Documentation

Education

Bachelor's degree in science/engineering

Job description

• Responsible for internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director.
• Assists the Regulatory Affairs Director with regulatory strategy/plans and requirements.
• Prepares worldwide regulatory submissions/registrations.
• Participates in the review and disposition of labeling, promotional materials and product modification.
• Prepares documentation and coordinates activities related to PMA's, 510k's, and IDE's.
• Supports engineering changes through RA/QA practices by documentating the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations.
• Participates in cross functional departmental team projects and product development activities/meetings.
• Provides support to RA Director for communication between Regulatory Agencies such as the Food and Drug Administration (FDA) and the European Notified Body.
• Responsible for FDA/ISO/MDD/CMDR compliance documentation.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

Qualifications

Bachelor's Degree in Scientific/Engineering discipline. A minimum of three years experience in a regulatory environment. Willingness to handle a number of projects simultaneously in a fast paced environment. Ability to assist in regulatory planning and strategies for domestic (510(k)/IDE/PMA) and international submissions/registrations. Ability to represent Regulatory Affairs to other departments.

Atrium Medical Corporation offers competitive salaries, exceptional benefits, and a business casual dress code. We do not accept unsolicited Agency Resumes. Atrium Medical Corporation is an equal opportunity employer dedicated to workforce diversity and a drug and smoke-free environment. Drug screening is required.