The Sr. Director, Global Policy Implementation serves as the Medical Device Regulatory Affairs (MD RA) leader designing and implementing cross-MD regulatory projects responding to regulatory policy and major business needs.
The Sr. Director identifies and assesses cross MD regulatory policy compliance as well as regulatory policy changes and major business needs that require MD RA implementation. Develops and implements regulatory policy strategy for compliance and remediation in partnership with other MD RA groups and business partners. S/he plans and directs resources and activities of a regulatory group to deliver business imperatives and maintain regulatory compliance. Drives effective business strategies to ensure regulatory programs are standardized to obtain earliest possible approvals and renewals. S/he manages regulatory policy implementation for cross-MD regulatory projects.
This role represents regulatory on cross MD Initiatives for significant programs of change that require understanding (e.g. all Franchise Principal-as-Manufacturer Teams; legal entity integration, etc.). May act as Franchise regulatory representative with FDA and other key regulatory bodies. S/he provides measurable input into the development and implementation of Regulatory Affairs processes, standards, or plans in support of the organization’s strategies, and manages MD RA Policy Implementation staff.
Qualifications
A minimum of a Bachelor’s Degree or equivalent with 12+ years of progressive experience (OR advanced degree with 10+ years of experience) is required. Experience in regulatory policy, or regulatory affairs leadership within the medical devices or related (healthcare, pharmaceutical) industry is preferred.
This position requires strong project management and implementation skills. People management experience is an asset. S/he must have highly advanced knowledge within area of expertise and an understanding of other disciplines within the function including direct experience in dealing with device applications.
Demonstrated experience in medical device regulatory approvals (for example 510(k), PMA and European approval process) is required. Exercises a high level of independent judgment and execution in anticipating, interpreting, evaluating and resolving complex organizational opportunities.
The ability to build strategic regulatory business partnerships, organizational capabilities, and aptitude to achieve results under demanding time constraints with expansive and changing priorities. Also, the candidate must have excellent communication skills and the ability to build and maintain relationships at all levels in the organization, with external customers and Regulatory Authorities.
This role will require approx. 25% domestic and international travel.
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Primary Location: North America-United States-Massachusetts-Raynham
Other Locations: North America, Europe/Middle East/Africa, Latin America, Asia Pacific
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Regulatory Affairs
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