Regulatory Affairs Specialist II - Merrimack, NH (Hybrid)

Getinge•Merrimack, NH

9d•Hybrid

About The Position

The Regulatory Affairs Specialist II position will 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.

Requirements

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, EU MDD, EUMDR, 21 CFR Part 820 - Quality System Regulation, and 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).

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.