About this role
Regulatory Affairs Spec
- Business Unit: Draeger Medical Systems, Inc., Job-ID: 1284
- Location: Andover
- Function: Quality
- Work Location: Hybrid
- Employment Type: Permanent
The Job Responsibilities
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)
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