Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

Location:

Merrimack, NH, US

Company:
Atrium Medical Corporation

Remote Work: 1-2 days at home (site based)

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).

Job duties:

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.

Please Apply at:

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

• 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
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.