Regulatory Affairs Specialist II

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Company Name: Atrium Medical Corporation

Job Location: 40 Continental Blvd., Merrimack NH 03054. Employer will allow hybrid work schedule.

Job title: Regulatory Affairs Specialist II

Education: Bachelor's degree in Scientific or engineering discipline.

SOC Code: 13-1041.07

SOC Occupation Title: Regulatory Affairs Specialists

Duration: Regular Hire

Work week: Full-time

Supervision Experience Required: No

Travel Required: No

Experience: 2 years of experience in Regulatory affairs or related. Requires skills and experience in the following:

• Working knowledge of ISO 13485 Medical device standards, EU MDD, EU MDR, and 21 CFR 820.
• Working knowledge of Quality System Regulation and FDA Consensus Standards.
• Good working knowledge of MS Office (Word, Excel, Outlook).
• Familiarity with regulatory planning and strategies for domestic and international submissions/registrations.
• Experience with Endovascular product line.

Job duties: The Regulatory Affairs Specialist IIposition collects information and documentation for routine submissions to regulatory agencies. Seeks out related documentation as required to request agency approvals or in response to agency requests. Update basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency. Compiles and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirements. Gathers regulatory submissions to be reviewed for compliance and submission standards. Tracks through review process to ensure timely submission. Support with Field Correction and Recall activities. Participates in the review and disposition of labeling, promotional material and product modifications. Prepares documentation and coordinates activities related to EuMDR, PMA's, 510(k)'s, and IDE's. Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, EuMDR, CMDR, and other international regulations. Assists in special projects as needed.

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.