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Sr Project Manager
Rochester, Minnesota  |  Remote
Contract Position
It appears that you have already applied to this job.
Applied on August 14, 2022
Job Id #57373 Posted June 29, 2022


Seeking a Senior Project Manager to help lead projects in the Software as Medical Device (SaMD) & Regulatory group. Please note the very specific project management experience we are seeking for this role:

 

Skills:
• 5+ years of experience of demonstrated project / technical program management / systems engineering experience with complex medical device R&D.
• Complete understanding and experience with regulated product development life cycle from concept to launch.
• Working knowledge of FDA Quality regulations related to medical device development and quality and regulatory standards 21 CFR 820, ISO 13485, 14971, 62304, 62366.
• Understanding of medical device DHF, DMR, and medical device regulatory submission deliverables.
• Identify stakeholders, understand needs of the customer, and facilitate early identification of potential safety risks for a variety of AI/ML software as medical device products.
• Experience educating and guiding novice teams through the regulated medical development lifecycle.
• Well-versed in cross-functional communications through development activities (Planning, Design Inputs/Outputs, Design Verification/Validation, Design Transfer).

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

EQUAL OPPORTUNITY EMPLOYMENT SURVEY

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You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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