Sr Regulatory Affairs Specialist - Shockwave Medical

Johnson & Johnson is recruiting for Senior Regulatory Affairs Specialist for Shockwave Medical Inc. located in Santa Clara, CA.

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Position Overview

The Sr. 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 Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a focus on the United States and the EU. Under direction of responsible Regulatory Affairs Management, acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and supports new product development.

Essential Job Functions

• Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.
• Outline submission and approval requirements in assigned geographies.
• In consultation with Regulatory Affairs Management, develop sound regulatory strategies in alignment with business priorities and update strategy based upon regulatory changes.
• Provide regulatory input and technical guidance 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, 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 submit high-quality regulatory submissions to authorities on time in US and EU. Support international regulatory team with submissions to other geographies (e.g., Canada, Australia, Japan, etc.).
• In consultation with responsible Regulatory Affairs Management, interact and negotiate directly with regulatory authorities during the development and review process to ensure submission approvals.
• Communicate application progress to internal stakeholders.
• Evaluate and maintain current regulatory policies, processes, procedures.
• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
• Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner.
• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
• Provide regulatory input for product recalls and recall communications.
• Support quality system and technical file/design dossier audits.
• Maintain regulatory files and tracking databases as required
• Evaluate import/export requirements.
• Identify emerging issues.
• Provide other US and EU 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.