Regulatory Affairs Specialist II

March 7

🗻 New Hampshire – Remote

Although this job is listed in New Hampshire, this company may be open to hiring remote in other states.

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

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Getinge

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Getinge is a global company that provides advanced medical technology and solutions to healthcare providers. It focuses on improving clinical outcomes, enhancing patient safety, and increasing operational efficiency within hospital environments. Getinge's product offerings include equipment and services for surgery, intensive care, and sterilization, complemented by digital health solutions. They are committed to supporting healthcare professionals in delivering quality care to patients across various medical settings.

Critical care • Surgical workflows • Infection control • Contamination prevention • Intensive care

10,000+ employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Post-IPO Equity on 2017-10

📋 Description

• 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, the MDD, EuMDR, CMDR, and other international regulations. • Assists in special projects as needed.

🎯 Requirements

• Bachelor's degree in a scientific or engineering discipline plus 2 years of experience with 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.

🏖️ Benefits

• 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