Regulatory Affairs Specialist

place 01845 Andover  24.08.2026 business Draeger Medical Systems, Inc.

• Business Unit: Draeger Medical Systems, Inc.,
  Job-: 1284
• Location: Andover
• Function: Quality
• Work Location: Hybrid
• Employment Type: Permanent

The Regulatory Affairs Specialist will work hybrid in our Andover, MA office.

The Regulatory Affairs Specialist will develop the basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures. This position will work with supervision to ensure continued market assess and ongoing regulatory compliance of the Draeger Patient Monitoring device portfolio in US and international markets. This position will support the gathering of regulatory intelligence to assist in the development of local, regional, and global regulatory strategies, and will support the execution of post market product lifecycle management.

Develops regulatory strategies by;

• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Assessment of options and milestones to de-risk development programs and align with current regulatory requirements and agency guidance.
• Documenting path(s) to regulatory approval in the Regulatory Affairs Plan (RAP)
• Developing clear rationales for Letter-to-File (LTF) for product changes that will not impact product approvals or clearances

Responsible for:

• The procurement, assembly, and packaging of the required deliverables for the submission of product registration and approval information as appropriate.
• Preparation and submission of regulatory documentation according to applicable regulatory requirements and guidelines
• Communication and interaction with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
• Review labeling and marketing literatures for compliance with regulatory requirements.

Responsible for providing product support in preparing US and non-US product submissions (510(k), Technical files, Canadian Licenses and International Registrations), by assessing the acceptability of quality, preclinical, and clinical documents in regulatory submissions to ensure compliance with applicable regulations.

Provide support for domestic (federal, state, and local) and International products registrations, by:

• Researching existing documentation, preparing summary information, memos or statements (including CFG’s; certifications, apostille, and consularization).
• Partnering with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
• Assess global impact of changes to launched products and support notifications/submissions as required

Provide import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate.

• Review labeling and marketing literatures for compliance with regulatory requirements
• Participates in the annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals.

Maintain knowledge and application skills of regulations, standards and codes within job scope by doing the following:

• Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products
• Monitor and evaluate medical device regulation changes and develop and execute strategies for maintaining products on the global market.

Performs other duties as needed and assigned.