Getinge · 18 hours ago
Regulatory Affairs Specialist II
Merrimack, NH, US
Full-time
Hybrid
Entry, Mid Level
2+ years expGetinge is dedicated to making life-saving technology accessible to more people and is seeking a Regulatory Affairs Specialist II. The role involves developing and compiling materials for regulatory submissions, ensuring compliance with guidelines, and supporting various regulatory activities related to medical devices.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Develop and compile materials, data, and supporting documentation for timely and compliant submission to regulatory authorities in accordance with applicable guidelines and requirements
Identify and obtain relevant documentation necessary to support regulatory approval requests or to respond to inquiries from regulatory authorities
Independently determine accurate regulatory information and deliver detailed global assessments, including required timelines and supporting evidence
Compile and track submissions that require review to ensure they meet regulatory submission standard policies, and operating procedure requirements
Modify or create Regulatory operating procedures as needed to ensure submissions meet requirements
Gather and organize regulatory submissions for evaluation against compliance and formatting standards, and track review progress through the review cycle to support ontime submission
Provide support for Field Correction and Recall activities
Participate in the review and disposition of labeling, promotional material and product modifications
Prepare state of the art documentation and coordinate activities related to European Union Medical Device Regulation (EuMDR), premarket approvals (PMAs), 510(k) premarket submissions, and investigational device exemptions (IDEs)
Support engineering changes through Regulatory Affairs (RA) and Quality Assurance (QA) practices by documenting the changes in compliance with the Quality Systems Regulation (CMDR), and other international regulations
Participate in special projects as needed, including but not limited to improvement projects, CAPA and Corporate initiatives
Qualification
Required
Bachelor's degree in a scientific or engineering discipline
2 years of experience in regulatory affairs or related
High-level ability to prepare and execute regulatory strategies for complex projects
Working knowledge of ISO 13485 Medical device standards
Working knowledge of EU MDD
Working knowledge of EUMDR
Working knowledge of 21 CFR Part 820 - Quality System Regulation
Working knowledge of FDA Consensus Standards and Guidance relevant to medical devices
Demonstrated ability to assist in regulatory planning and strategies for domestic and international submissions/registrations
Working knowledge of MS Office (Word, Excel, Outlook)
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
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