• Ethosia
  • Crystal Lake , IL
  • Non-Executive Management
  • Full-Time
  • 6000 Dvorak Dr


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Medical Device Start-up that has set out on a mission to help hundreds of millions of people receive access to fast, accurate medical diagnosis, by teaching computers to read and diagnose medical imaging data.

As the Regulatory Affairs Manager, you will be accountable for the development and implementation of all products regulatory strategy and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the products and the needs identified by the business, markets and patients.
Planning, undertaking and overseeing product/clinical trials and regulatory inspections
Keeping up to date with changes in regulatory legislation and guidelines
Offering advice about company policies, practices and systems
Liaising and negotiating with regulatory authorities
Ensuring that quality standards are met and submissions meet strict deadlines
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Coordinate successful submissions and approval of all applications
Manage a small team of regulatory affairs specialists

Requirements:
10+ years of experience at medical device industry, in a regulatory affairs position
5 plus years managerial/supervisory experience, with 2 or more direct reports.
Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US and EU: Class III Medical Devices: IDE, PMA HDE, 510(k) and EU Design Dossiers.
Strong technical knowledge of medical device products.
Comprehensive understanding of relevant medical procedures, practices, terminology, and products.
Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.
Fluent English, oral and written
Proven leadership and project management experience.
Ability to think strategically and critically evaluate risks to regulatory activities.
Successful contribution to a major regulatory approval at a global or regional level.
Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking the big picture view on various options
Team-player, able to positively influence team members at all levels with an entrepreneurial can do attitude
Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
Bachelor's Degree or equivalent work experience, preferably in a scientific or technical discipline.



* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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