【Shockwave】Associate Director, Regulatory Affairs

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
Chuo-ku, Tokyo, Japan

Job Description:


* Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units


* Manage, mentor, and develop direct reports to meet individual and company goals and objectives


* Develop, follow, and train key personnel on regulatory policies, processes and SOPs


* Develop and implement regulatory strategies and update strategy based upon regulatory changes


* Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order to effectively meet the requirements


* Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development and operations teams


* Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)


* Effectively and accurately write and edit technical documents


* Review and approve R&D, quality, preclinical and clinical documentation for submission filing


* Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements



* Provide guidance to functional groups in the development of relevant data to complete a regulatory submission


* In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)


* Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals


* Effectively communicate application progress to internal stakeholders


* Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies. 


* Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies


* Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation


* Pro...