Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

Location

Merrimack, NH, US

Company Atrium Medical Corporation

Overview

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.

Job Details

Job Location: Merrimack, NH 03054 Employer will allow a hybrid work schedule.

Job title: Regulatory Affairs Specialist II

Education: Bachelor's degree in a 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 Experience: 2 years of experience in regulatory affairs or related.

Requires skills and experience to involve:

• 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

• 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 cha

• Qualification

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Benefits

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