Overview
Johnson & Johnson is recruiting for Shockwave Medical Inc. a Principal Regulatory Affairs Specialist, to be located in the UK (Fully Remote role).
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Principal Regulatory Affairs Specialist is an individual contributor that works closely with internal departments to efficiently meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The role 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, the incumbent works independently, acts as a decision-maker on regulatory issues, ensures that registrations/renewals and deadlines are met, and supports new product development as assigned.
Essential Job Functions
* Collaboratively interface with a variety of levels on significant matters, often across organizational units.
* Develop regulatory policies, processes and SOPs and train key personnel on them.
* Develop regulatory strategies and update strategy based on regulatory changes.
* Determine submission and approval requirements in assigned geographies and 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 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.
* Collaborate with cross-functional team members to compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan).
* Interact and negotiate with regulatory authorities during development and review 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 requirements and identify emerging issues.
* Provide other country specific regulatory support; 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 regulatory submissions.
* Other duties as assigned.
Requirements
* Typically requires a minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 4 years experience; or equivalent experience.
* Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred.
* Ability to work collaboratively in a fast-paced environment while managing multiple priorities.
* Detailed working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
* Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and international filings (TGA, Health Canada, Shonin, CFDA, etc.).
* Ability to outline sound regulatory strategy in alignment with regulations and business priorities; strong analytical and problem-solving skills.
* Effective negotiation with regulatory agencies; clear written and verbal communication with diverse audiences.
* Knowledge of business functions and cross-group dependencies; leadership in developing data for regulatory submissions.
* Ability to follow scientific arguments, identify data needs and solve regulatory issues; works as a team or independently with flexibility.
* Some medical device software engineering background or experience is preferred.
* Proficiency in MS Word, Excel and PowerPoint.
Employment Details
* Employment type: Full-time
* Job function: Legal
* Industries: Hospitals and Health Care
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