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Post Market Surveillance Manager

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Our partner is an exciting start-up technology that uses neuromodulation to fix a challenging problem that improves patient outcomes and creates significant cost savings to the industry, as well. Currently, the company is selling its product internationally and is close to getting FDA approval, which will lead to adding the right talent to the US team. It is a great leadership team with extensive industry experience, successfully bringing positive products to the market. SSI is supporting multiple critical roles as they grow their US Team, including a Post Market Surveillance Leadership position. This important position will do a gap assessment on their current MDR processes and be integral in setting up their PMS complaint program and all vigilance activities.

The Right Talent:

Leadership experience with direct reports and building/mentoring teams

BS in Engineering, Science, Lifesciences, or a relevant degree

7+ Years of relevant experience supporting Class II & III medical devices

Experience with PSUR and MDR activities

Experience with complaints, complaint trend analysis, vigilance, and recall activities

Experience with ISO 14971 & 13485

Strong experience collaborating with R&D, RA, Operations, & Manufacturing to ensure product quality

Experience supporting audits, product reliability, and product safety

Permanent and Remote Opportunity

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