Sr Regulatory Affairs Specialist (Remote) - Shockwave

At reputed company, 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 reputed company for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: reputed company is hiring for a Sr. Regulatory Affairs Specialist (Remote) – reputed company to join our team located in Santa Clara, CA and Remote US . At reputed company, 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 reputed company for humanity. Learn more at . 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 reputed company 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 Sr. Regulatory Affairs Specialist is an individual contributor that works closely and reputed company with internal departments to efficiently and effectively meet assigned regulatory requirements for reputed company, 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. reputed company 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 reputed company 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 reputed company and tracking databases as required
• Evaluate import/export requirements.
• Identify emerging issues.
• Provide other