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JOB DESCRIPTION:

Johnson & Johnson MedTech is recruiting a Senior Regulatory Affairs Specialist for Shockwave Medical, hybrid-role office based role in Wokingham.

ROLE PURPOSE:

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). They combine knowledge of scientific, regulatory and business issues to ensure that products meet regulatory requirements with a focus on the EU, UK, Switzerland, and other geographies as assigned. 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.

WHAT YOU WILL BE DOING:

• 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).
• In collaboration with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and assigned geographies. Support international regulatory team with submissions to other geographies. (
• 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.
• In collaboration with the Regulatory Affairs team, 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 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
• Identify emerging issues.
• 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.