Principal Regulatory Affairs Specialist

1 week ago

Seattle, United States Disability Solutions Full time
Johnson & Johnson is recruiting for Principal Regulatory Affairs Specialist Shockwave Medical Inc. Hybrid Remote, Seattle, Washington.

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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/.

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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

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At Johnson & Johnson, we all belong.

Position Overview

The Principal Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. Under direction of responsible Regulatory Affairs Management, works independently with minimal oversight, acts as a decision-maker on regulatory issues, assures that registration/renewal and other deadlines are met, and supports new product development, post-approval change management and J&J integration as assigned.

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Essential Job Functions
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  • Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.
  • Develop regulatory policies, processes and SOPs and may train key personnel on them.
  • Lead and execute assigned integration projects.
  • Lead implementation of continuous improvement updates to internal policy and procedures in response to changing regulations, standards, internal and external audits.
  • Develop regulatory strategies and update strategy based upon regulatory changes.
  • Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders
  • Provide input and technical guidance on regulatory requirements to 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).
  • Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
  • In collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US, as assigned (e.g., EU, Canada, Australia, Japan, etc.).
  • Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals.
  • Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
  • Oversee 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.
  • Provide regulatory input for product recalls and recall communications.
  • Review and approve advertising and promotional materials to ensure regulatory compliance.
  • Evaluate import/export requirement.
  • Identify emerging issues.
  • Provide other country specific regulatory support.
  • Effectively and accurately write and edit technical documents.
  • Plan and conduct meetings, create project plans and timelines, and manage projects.
  • Exercise good and ethical judgment within policy and regulations.
  • Perform multiple tasks concurrently with accuracy.
  • Provide guidance to functional groups in the development of relevant data to complete a regulatory submission.
  • Other duties as assigned.
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