The Regulatory Affairs Program Director will direct and guide strategies for the CRHF implementation of, and full compliance to the European Union Medical Device Regulation (EU MDR). This role will provide overall leadership and strategic direction to the EU MDR program team and extended CRHF work stream teams in the development and execution of strategies to achieve EU MDR compliance. This role has direct responsibility and accountability for execution of the EU MDR implementation. This role will work across geographies and functions.
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POSITION RESPONSIBILITIES
• Collaborate across multiple CRHF functions, including Research and Development, Quality, Packaging Engineering, Sourcing, Clinical, Regulatory Affairs, Technical Communications and Operations colleagues in CRHF and Corporate to develop a an EU MDR implementation strategy and execution plan which will achieve full compliance to regulations within the predefined timetable of April 2020.
• Work within global CRHF organization to form suitable teams to define and execute a prioritized plan while gaining organizational alignment
• Responsible for communicating with key stakeholders (e.g., CRHF Sr. Staff, team members), globally and across CRHF, the broader corporation.
• Prepare regular briefings and participate in the governance/oversight model that ensures confidence in the outcomes of the EU MDR
• Provide innovative and strategic guidance for CRHF portfolio rationalization and remediation to achieve EU MDR compliance.
• Collaborate with and influence CRHF key stakeholders and EU MDR steering Committee composed of CRHF senior staff and functional leaders.
BASIC QUALIFICATIONS
EDUCATION REQUIRED
Bachelor’s degree in Engineering, Life Sciences or related medical/scientific field
YEARS OF EXPERIENCE
• 10+ years’ experience in the medical device industry in a regulatory, clinical, R&D or quality function
SPECIALIZED KNOWLEDGE REQUIRED
• Interpretation of global regulations governing medical devices. In depth project management skills.
DESIRED/PREFERRED QUALIFICATIONS
• Proven experience with strategy development, critical thinking and regulation interpretation supporting the commercialization of high-risk permanent implantable devices.
• Expertise in project management and negotiations with global regulators
• Strong organization skills with ability to manage multiple projects simultaneously.
• Ability to lead by influence across a large matrix organization
• Strong analytical abilities coupled with creative problem solving skills.
• Advanced degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field, or MBA.
• Excellent oral and written communication skills; effective interpersonal and influence skills
• Comfortable with minimal supervision while maintaining good communication.
• Ability to travel up to 25% time.
• History of working collaboratively across functions and geographies
• Proven ability to comprehend principles of regulation, quality systems, portfolio rationalization and medical device operations
• Expertise in global quality system requirements
• Experience working cross-culturally.
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