Getinge · 3 days ago
Regulatory Affairs Specialist II
Merrimack, NH
Full-time
Hybrid
Entry, Mid Level
2+ years expGetinge is dedicated to making life-saving technology accessible to more people. The Regulatory Affairs Specialist II will be responsible for collecting and managing documentation for regulatory submissions, ensuring compliance with standards, and supporting various regulatory activities.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
The Regulatory Affairs Specialist II position 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
Qualification
Required
Bachelor's degree in Scientific or engineering discipline
2 years of experience in Regulatory affairs or related
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
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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