Regulatory Affairs Specialist II - Merrimack, NH (Hybrid)

About the role

The Regulatory Affairs Specialist II position at Atrium Medical Corporation in Merrimack, NH, offers an inspiring career for those passionate about making a difference in healthcare. This role involves developing and compiling materials for regulatory authorities, gathering necessary documentation, and supporting various regulatory processes.

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 on-time 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 field.
• 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).

Qualifications

• No supervision experience required.

Skills

• 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).

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.

Pay

Details on pay are not specified in the job posting.

Schedule

The work week is full-time, and the position offers a hybrid work schedule.