Business Unit: Point of Care
Requisition Number: 247114
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 20%
Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business Area piques your interest, then this opportunity is for you! We are looking for an experienced clinical operations leader to join our enthusiastic and collaborative team.
The selected senior professional will:
- Plan, execute and manage multiple complex regulatory submissions for in vitro diagnostic devices for global launch.
- Take responsibility of ensuring the execution of regulatory submissions with the goal of adhering to target timelines, budget and quality.
- Reports to Sr. Manager, Regulatory Affairs - Point of Care (POC) Business Line.
- Represent Regulatory Affairs on Product Development Core Teams for Point of Care (POC) Diagnostics for in vitro diagnostic (IVD) devices.
- Effectively plan, execute and manage regulatory deliverables for complex immunoassay IVDs, including 510(k)s, Pre-Submissions, CE-Mark Notified Body STED submissions and other regulatory submissions worldwide.
- Manage multiple complex projects simultaneously according to project timelines.
- As the RA Lead on development core teams, this individual must effectively interpret and apply regulatory requirements for launch into US, EU, Asia Pacific and other countries as required and provide guidance to the project teams for proper execution of submissions according to tight timelines.
- Performs review of promotional material for regulatory compliance according to country specific requirements.
- Individual is recognized as a disciplined expert and resource in Regulatory Affairs.
- Provides guidance and coaching to fellow regulatory peers.
- Interacts closely with other functions such as Clinical Affairs, Quality Systems, Manufacturing, R&D and Labeling.
· Minimum of 10 years experience in Regulatory Affairs, preferably with a global manufacturer of medical devices.
· Must have demonstrated success with 510(k) and/or PMA, or other complex regulatory submissions.
· Must have experience interacting with FDA.
· Must have strong knowledge of EU IVDR/MDR regulations.
· Must have experience working on multidisciplinary teams in a fast-paced, dynamic environment.
· Must have experience reviewing product labeling, including advertising/promotional materials.
· Must have a team-player attitude and have strong written and verbal communication skills.
· Ability and willingness to travel, depending upon project need (both domestically and internationally) approximately 20%.
· Experience with immunoassay IVD regulatory submissions (PMAs, 510(k), CE Mark etc.) a plus.
· Successfully passed Regulatory Affairs Certification (RAC) a plus.
· BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.