Executive Director, Reg Affairs, Quality Systems and Clinical

Proclinical is currently recruiting for an Executive Director of Regulatory Affairs, Quality Systems and Clinical Affairs with a global imaging company located in Newark, NY. As the Executive Director, you will execute comprehensive programs related to regulatory affairs, quality systems, post market, clinical studies, and corporate compliance with applicable global medical device regulations and standards.

Job Responsibilities:

• Provide strategic regulatory guidance to the Executive Leadership Team (ELT).
• Directly supervise Central Regulatory professionals and provide guidance to "dotted-line", in-region regulatory teams.
• Ensure adoption of Good Clinical Practice, Good Manufacturing Practice, Good Laboratory Practice, Good Document Practice, Computer Controls & Validation, Regulated IT, Inspection Readiness, Unique Device Identifier, and other regulations as identified.
• Provide vision and strategic direction to support product commercialization efforts, post market activities and clinical investigations.
• Partner with business to effectively simplify and maintain compliance of QM System.
• Represent the company with FDA, Health Canada and other Health Authorities/Government Entities as applicable.
• Influence global regulatory authorities and/or lawmakers.
• Provide regulatory guidance on developing, conducting and monitoring clinical investigations.
• Oversee the effective implementation of MDSAP and MDR compliance.
• Continued operational execution of Quality and Regulatory process simplification activities.
• Maintain overall compliance of product portfolio including certifications, licenses, and impact from changing regulations.
• Interact with operations, product development, legal, consultants, and regulatory authorities.
• Develop effective processes to facilitate faster market penetration in global markets.
• Oversee global regulatory and quality councils to ensure adequate communication and consistency with compliance efforts.
• Monitor US and international registration developments to proactively recognize changes in medical device regulations and respond with strategy and process changes as needed to ensure registration processes are compliant, efficient and effective.
• Oversee efforts to maintain Master Control, our application of choice for document control.
• Plan and manage department budget.

Skills and Requirements:

• Minimum Bachelor of Science degree, with a strong preference for a MS or Ph.D. in a primary science/medical science, pharmacy, engineering or related technical field (or other relevant discipline)
• Minimum 10 years of Regulatory/Quality leadership in a medical device company
• Minimum 5 years of active engagement with FDA
• Demonstrates leadership and is viewed as subject matter expert in all areas of the regulated business
• Hands-on experience in Regulatory Affairs, Quality, Quality Systems, and Clinical Affairs
• Self-starter, self-driven, uses independent judgment, adaptive and prioritizes challenges
• International work experience in pharma, biotech or device preferred
• Knowledge of global Medical Device Regulations including product registration requirements, quality system requirements and clinical requirements
• Demonstrate leadership of growing effective teams and implementing strategic processes
• Ability to effectively handle simultaneous tasks and prioritize accordingly
• Ability to assess regulatory risks and remediate where necessary
• Demonstrate excellent written, oral and interpersonal skills with personnel at all levels
• Exhibit a high degree of integrity, initiative and motivation
• Established contacts with key regulatory decision makers in the governments and industry required
• Experience with successful interaction dealing with the FDA and other Health Authorities
• Experience with successful interaction dealing with ISO authorities including BSI, GMED, TUV, etc.
• Leadership experience in risk management, problem solving and issue management

If you are having difficulty in applying or if you have any questions, please contact Dove Jociute at d.jociute@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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