Senior Project Manager Clinical Evaluation

** Job Description Senior Project Manager, Clinical Evaluation
** The function of a Clinical Evaluation Report Project Manager supporting our Structural Heart Clinical Evaluation Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices:
Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under (MEDDEV 2.7/1 Rev
4) and EU Regulation 2017/745. The role of PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle. The position reports to the Sr. Manager of Clinical and Risk Evaluations.
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* Main Responsibilities:

** strategic guidance on regulatory requirements
** Required Qualifications**:
Minimum 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area Minimum 3-4 years experience in a regulated industry (e.g., medical products, nutritionals).

Note:

Higher education may compensate for years of experience.

Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Principles and requirements of applicable product laws Submission/registration types and requirements Principles and requirements of promotion, advertising and labeling and territorial trade requirements, Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws Submission/registration types and requirements Principles and requirements of promotion, advertising and labeling and territorial trade requirements, Has broad knowledge of various technical alternatives and their potential impact on the business Use in-depth knowledge of business functions and cross group dependencies/ relationships Define regulatory strategy with supervision Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
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* Preferred Qualifications:

** Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device Effective written, verbal and presentation skills in the area of technical/clinical applications

Project management and/or management of people experience Demonstrated ability to identify and adapt to shifting priorities and competing demands

Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time Experience in structural heart / structural intervention devices
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