CRO Responsibilities • Implementation of the regulatory strategy, risk management and continuous improvement projects to achieve business objectives. o Review and advise on all material FDA and global regulatory submissions/or registration strategies for product approvals or clearances. Review and approval of all FDA, NB requests and other regulatory agency inquiries. o Review and advise the management on product risk assessments and global change assessments. o Oversee risk management activities that can impact registration or business growth strategies of the business. o Build a team with capabilities to support the short-, mid- and long-term goals of the company. • Developing regulatory strategies and tactics, including building external partnerships, designed to achieve global product clearances and approvals faster and in compliance with relevant regulations and law. Actively participates on the RA Leadership team and regulatory trade associations operation projects, among other things. • Partners with Quality to ensure policies and procedures align with the Eitan Group Quality System. • Lead and/or facilitate team preparation for regulatory agency/Health Authority meetings Lead and/or facilitate communications with global regulatory agencies • Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents. • Develop, define and lead internal growth and resourcing strategy for Global Regulatory Affairs within the organization the members of the regulatory affairs teams.
Direct Manager: VP RA QA
Bachelor of Science Degree in a Life Science or Engineering field is required
Advanced degree preferred (MS, PhD, MBA)
Job skills: Requirements:
Minimum of 10-15 years of medical device and/or pharmaceutical experience, directly working on regulatory filings required
At least 7 years of direct management
Recent experience leading meetings with FDA/CDRH for new device products – a Must
RAC certified a plus, but not required.
Global regulatory experience combined with a desire to learn, investigate, and research global regulations, guidance’s and industry standards
Thorough understanding of medical device and combination product associated national regulations, and general knowledge of international regulations. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as subject matter expert in multiple areas
Independently authors written reports/documents for distribution within division.
Recognizes potential problems and proposes solutions
Assesses potential impact and/or applicability to other related areas within unit and business.
Assesses corrective action to assure it prevents recurrence.
Able to confidently deal with ambiguous issues and provide input towards suitable actions.
Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.
Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.
Manages and monitors multiple complex and diverse projects simultaneously, including projects that involve several functional areas.
Ability to link regulatory strategy, tactics, and outcomes to business strategy
Ability to create and sustain a results-oriented culture
Strong business acumen
Ability to influence through effective communication, people management, and leadership skills.
Ability to work independently and proactively
Ability to work effectively in a cross-functional team
Complexity of Duties:
Working in a matrix, across organizational boundaries and within ambiguous environments.
Works on complex issues in a cross-cultural business environment.
Ability to manage multiple priorities at the same time.
Must operate with a sense of urgency.
Ability to travel domestic and internationally as necessary
English- Strong verbal and written communication skills
A team player
Ability to multi-task and work well within a dynamic, fast-paced organization
Organized, paying attention to the small details
* משרה מס׳ #107112 מיועדת לגברים ונשים כאחד