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Associate Director, Regulatory Affairs- Medical Devices
Whippany, NJSourcePro Search is conducting a search for an Associate Director, Regulatory Affairs- Medical Devices.
The Associate Director develops and implements regulatory strategies for new and existing devices within the United States Bayer Consumer Care portfolio. The incumbent will ensure all relevant FDA device guidance and standards are adhered too. The incumbent will also ensure close alignment of the development team with R&D functions, Product Supply and Quality Assurance and serve as the CMC/device interface on all regulatory matters involving Bayer’s Consumer Care device portfolio partners.
More specifically related to this role, the incumbent will have responsibilities including, but not limited to:
• Develop and implement innovative regulatory strategies for Consumer Care device development in the US, enabling devices to get to market as quickly as possible. This position will author and review regulatory documentation, including regulatory assessments for device development initiatives and due diligence activities, and clearly communicate recommendations to cross-functional teams and senior management.
• Lead and/or participate in cross-functional and regulatory project teams working on developing product claims for labeling and promotion, as well as, commercialization of new devices. Translate regulatory strategy into clear and measurable objectives for team members and ensure that the appropriate processes are defined and followed.
• Act as company liaison to FDA for Consumer Care devices and communicate results of these interactions with the organization. Develop strategies to address FDA requests and requirements, present to senior management as needed and lead execution of strategy. Prepare and coordinate accurate and timely submissions to FDA.
• Ensure regulatory compliance of marketed devices. Post approval maintenance activities include change controls, annual reports, supplements, amendments and DHF maintenance activities.
• Proactively identify regulatory issues/risks and design/execute mitigation plans.
• Maintain current knowledge of regulations and industry environment and provide guidance on potential and evolving trends. Review and suggest possible organization reaction to new or proposed legislation.
• May act as a company liaison to industry trade associations.
• Create and manage strong network with key stakeholders such as marketing, legal, and other scientific personnel that facilitate collaboration.
• The incumbent should be capable of performing these tasks with minimal supervision.
Qualifications:
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. Related to this position, we are seeking an incumbent who possess the following:
• Graduate degree in the life sciences or engineering or equivalent combination of education and experience:
• Advanced degree in life sciences or engineering with at least six (6) years of pharmaceutical medical device experience, preferably with Class 1 and 2 devices
• Bachelor’s degree in life sciences or engineering will be considered with at least 10 years of pharmaceutical medical device experience, preferably with Class 1 and 2 devices
• Substantial experience multitasking in a deadline controlled and highly regulated environment.
• Strong communication skills, in English verbally and in writing, are required in order to clearly and effectively interact internally at varying levels as well as externally with health authorities and industry associations.
• Team and customer orientation
• Proficiency in MS Office
• Ability to accommodate changes and communicate them effectively
• Results orientation
• Successful track record in contributing to /managing cross- functional teams
• Business savvy and commercial orientation
• Strategic orientation.
The Associate Director develops and implements regulatory strategies for new and existing devices within the United States Bayer Consumer Care portfolio. The incumbent will ensure all relevant FDA device guidance and standards are adhered too. The incumbent will also ensure close alignment of the development team with R&D functions, Product Supply and Quality Assurance and serve as the CMC/device interface on all regulatory matters involving Bayer’s Consumer Care device portfolio partners.
More specifically related to this role, the incumbent will have responsibilities including, but not limited to:
• Develop and implement innovative regulatory strategies for Consumer Care device development in the US, enabling devices to get to market as quickly as possible. This position will author and review regulatory documentation, including regulatory assessments for device development initiatives and due diligence activities, and clearly communicate recommendations to cross-functional teams and senior management.
• Lead and/or participate in cross-functional and regulatory project teams working on developing product claims for labeling and promotion, as well as, commercialization of new devices. Translate regulatory strategy into clear and measurable objectives for team members and ensure that the appropriate processes are defined and followed.
• Act as company liaison to FDA for Consumer Care devices and communicate results of these interactions with the organization. Develop strategies to address FDA requests and requirements, present to senior management as needed and lead execution of strategy. Prepare and coordinate accurate and timely submissions to FDA.
• Ensure regulatory compliance of marketed devices. Post approval maintenance activities include change controls, annual reports, supplements, amendments and DHF maintenance activities.
• Proactively identify regulatory issues/risks and design/execute mitigation plans.
• Maintain current knowledge of regulations and industry environment and provide guidance on potential and evolving trends. Review and suggest possible organization reaction to new or proposed legislation.
• May act as a company liaison to industry trade associations.
• Create and manage strong network with key stakeholders such as marketing, legal, and other scientific personnel that facilitate collaboration.
• The incumbent should be capable of performing these tasks with minimal supervision.
Qualifications:
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. Related to this position, we are seeking an incumbent who possess the following:
• Graduate degree in the life sciences or engineering or equivalent combination of education and experience:
• Advanced degree in life sciences or engineering with at least six (6) years of pharmaceutical medical device experience, preferably with Class 1 and 2 devices
• Bachelor’s degree in life sciences or engineering will be considered with at least 10 years of pharmaceutical medical device experience, preferably with Class 1 and 2 devices
• Substantial experience multitasking in a deadline controlled and highly regulated environment.
• Strong communication skills, in English verbally and in writing, are required in order to clearly and effectively interact internally at varying levels as well as externally with health authorities and industry associations.
• Team and customer orientation
• Proficiency in MS Office
• Ability to accommodate changes and communicate them effectively
• Results orientation
• Successful track record in contributing to /managing cross- functional teams
• Business savvy and commercial orientation
• Strategic orientation.