Requisition ID 14280BR
Title Associate Director, Regulatory Affairs - Medical Devices
Job Category Regulatory Affairs
Job Description PURPOSE:
Selected candidate for this newly created opportunity will oversee all assigned projects/products/processes as they relate to regulatory approvals for Novo Nordisk products, with specific focus on projects relating to Human Factors Validation Testing. This will be accomplished via assurance of Novo Nordisk compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Position would also act as liaison with FDA for assigned projects, and supervises designated project personnel.
RELATIONSHIPS:
Report to the Sr. Director Regulatory Affairs. Interact with key company personnel both within and outside of Novo Nordisk-US as related to assigned projects. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments in support of initiatives and to accomplish company goals. FDA liaison for designated projects or as requested by supervisor. Supervises junior Regulatory Affairs staff.
ESSENTIAL FUNCTIONS:
Act as liaison with NNI and NNAS departments for preparation of documentation necessary for submission of applications.
Approve specified regulatory submissions.
Assist senior Regulatory Affairs personnel in assuring compliance.
Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products, 510(k) devices and medical device/pharmaceutical combination products under development or license for assigned projects.
Facilitate and organize the compilation of applications (IND, NDA, Biologics, 510(k) Devices, combination products) to government agencies in support of investigational and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications.
FDA liaison on key matters.
Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department.
Lead FDA meetings.
Lead major label negotiations.
Major labeling negotiation.
Manage complex projects.
May act as FDA liaison for all project issues.
May act as GRT member.
Participate in and/or coordinate all negotiations and interacts with FDA personnel as assigned.
Provide information and training for NNAS in areas of US IND, NDA, 501(k) and combination product processes. Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects, including CDRH human factors engineering guidances.
Provide input as requested for device design and process verification and validation activities; review and collate documentation required for 510(k) and medical device/pharmaceutical combination product FDA submissions.
Provide input into development of regulatory and quality systems.
Provide input into development of SOPs for the efficient operation of the department and inter-department activities.
Responsible for development of regulatory submission strategies.
Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
Submit all types of applications to FDA.
Supervise and advise staff members.
Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.
Supervise the review and sign off on instructions for use and other product labeling as necessary to comply with FDA requirements for investigational and marketed 510(k) device and combination products.
PHYSICAL REQUIREMENTS:
Some overnight travel
DEVELOPMENT OF PEOPLE:
Contribute to development of Associates and Managers.
Ensure that reporting personnel have timely performance evaluation forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
For global projects, advise members of the global regulatory team and provide input to goal setting and performance appraisal for team members in headquarters within assigned projects.
Manage assigned junior to more experienced personnel and their simple projects or portions of projects as direct report(s).
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Bachelor's degree in Engineering with direct/indirect regulatory affairs experience from the medical device industry (i.e. device development),
OR
Bachelor’s degree in life science or related area required with direct regulatory experience. Advanced degree may be substituted for relevant experience when appropriate.
A minimum of 10 years related experience (i.e. pharmaceutical, medical device/pharmaceutical combination product, clinical research, or laboratory exp.) including at least 6 years direct or indirect regulatory experience is required. Indirect experience from the medical device industry includes regulatory requirements pertaining to quality system standards for device development and manufacture and device performance or experience of development requirements for devices containing software and hardware components. Knowledge and experience with FDA Human Factors Validation Testing requirements is required.
Ability to establish sound working relationships.
Ability to work independently.
Detail & deadline oriented; well organized.
Excellent verbal and written communication skills essential.
Experience and knowledge of the relevant current requirements of FDA required.
For global projects, prior interaction or exposure with other key regulatory authorities either as regulatory or subject matter expert e.g. EMEA, EU national authorities, PMDA.
Good interpersonal skills; ability to interact with staff on all levels.
Department CMR - THERAPEUTIC AREA (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Title Associate Director, Regulatory Affairs - Medical Devices
Job Category Regulatory Affairs
Job Description PURPOSE:
Selected candidate for this newly created opportunity will oversee all assigned projects/products/processes as they relate to regulatory approvals for Novo Nordisk products, with specific focus on projects relating to Human Factors Validation Testing. This will be accomplished via assurance of Novo Nordisk compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Position would also act as liaison with FDA for assigned projects, and supervises designated project personnel.
RELATIONSHIPS:
Report to the Sr. Director Regulatory Affairs. Interact with key company personnel both within and outside of Novo Nordisk-US as related to assigned projects. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments in support of initiatives and to accomplish company goals. FDA liaison for designated projects or as requested by supervisor. Supervises junior Regulatory Affairs staff.
ESSENTIAL FUNCTIONS:
Act as liaison with NNI and NNAS departments for preparation of documentation necessary for submission of applications.
Approve specified regulatory submissions.
Assist senior Regulatory Affairs personnel in assuring compliance.
Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products, 510(k) devices and medical device/pharmaceutical combination products under development or license for assigned projects.
Facilitate and organize the compilation of applications (IND, NDA, Biologics, 510(k) Devices, combination products) to government agencies in support of investigational and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications.
FDA liaison on key matters.
Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department.
Lead FDA meetings.
Lead major label negotiations.
Major labeling negotiation.
Manage complex projects.
May act as FDA liaison for all project issues.
May act as GRT member.
Participate in and/or coordinate all negotiations and interacts with FDA personnel as assigned.
Provide information and training for NNAS in areas of US IND, NDA, 501(k) and combination product processes. Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects, including CDRH human factors engineering guidances.
Provide input as requested for device design and process verification and validation activities; review and collate documentation required for 510(k) and medical device/pharmaceutical combination product FDA submissions.
Provide input into development of regulatory and quality systems.
Provide input into development of SOPs for the efficient operation of the department and inter-department activities.
Responsible for development of regulatory submission strategies.
Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
Submit all types of applications to FDA.
Supervise and advise staff members.
Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.
Supervise the review and sign off on instructions for use and other product labeling as necessary to comply with FDA requirements for investigational and marketed 510(k) device and combination products.
PHYSICAL REQUIREMENTS:
Some overnight travel
DEVELOPMENT OF PEOPLE:
Contribute to development of Associates and Managers.
Ensure that reporting personnel have timely performance evaluation forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
For global projects, advise members of the global regulatory team and provide input to goal setting and performance appraisal for team members in headquarters within assigned projects.
Manage assigned junior to more experienced personnel and their simple projects or portions of projects as direct report(s).
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Bachelor's degree in Engineering with direct/indirect regulatory affairs experience from the medical device industry (i.e. device development),
OR
Bachelor’s degree in life science or related area required with direct regulatory experience. Advanced degree may be substituted for relevant experience when appropriate.
A minimum of 10 years related experience (i.e. pharmaceutical, medical device/pharmaceutical combination product, clinical research, or laboratory exp.) including at least 6 years direct or indirect regulatory experience is required. Indirect experience from the medical device industry includes regulatory requirements pertaining to quality system standards for device development and manufacture and device performance or experience of development requirements for devices containing software and hardware components. Knowledge and experience with FDA Human Factors Validation Testing requirements is required.
Ability to establish sound working relationships.
Ability to work independently.
Detail & deadline oriented; well organized.
Excellent verbal and written communication skills essential.
Experience and knowledge of the relevant current requirements of FDA required.
For global projects, prior interaction or exposure with other key regulatory authorities either as regulatory or subject matter expert e.g. EMEA, EU national authorities, PMDA.
Good interpersonal skills; ability to interact with staff on all levels.
Department CMR - THERAPEUTIC AREA (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required