Senior Regulatory Affairs Specialist, Shockwave, Pinewood

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.

Johnson & Johnson MedTech is recruiting a Senior Regulatory Affairs Specialist, hybrid-role, Pinewood, UK. About Shockwave: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease? 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.

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.

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).
• 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.

Requirements:

• Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work 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.
• Must be able to travel as needed.
• Working knowledge of applicable regulatory guidelines, policies and regulations.
• Experience with pre- and post-market medical device submissions such as, EU Technical Files, Design Dossiers.
• Experience with international submissions is a plus (UK, MDR, Swiss MeDO).
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
• Clear and effective verbal and written communication skills with diverse audiences and personnel.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Some medical device software engineering background or experience is preferred.
• Proficiency in MS Word, MS Teams, Excel, Adobe and Power Point.