Santa Clara, California, The Senior Manager, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Manager, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with responsible Regulatory Affairs management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Senior Manager, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.
Essential Job Functions
Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units
Manage, mentor, and develop direct reports to meet individual and company goals and objectives
Develop, follow, and train key personnel on regulatory policies, processes and SOPs
Develop and implement regulatory strategies and update strategy based upon regulatory changes
Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order to effectively meet the requirements
Provide strategic input and technical guidance on regulatory requirements to Regulatory, 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, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
Effectively and accurately write and edit technical documents
Review and approve R&D, quality, preclinical and clinical documentation for submission filing
Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
Effectively communicate application progress to internal stakeholders
Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
Direct 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
In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives
Review and approve advertising and promotional materials to ensure regulatory compliance
Evaluate, provide guidance and implement import/export requirements
Identify emerging issues and regularly communicate status
Provide other country specific regulatory support
Plan and conduct meetings, create project plans and timelines, and manage projects
Exercise good and ethical judgment within policies and regulations
Perform multiple tasks concurrently with accuracy
Other duties as assigned
Bachelor's degree in science, math, engineering, or medical fields is preferred. Post-graduate degree in a technical area, M.B.A. or law is preferred
Minimum 12 years’ experience in a regulated healthcare industry. Class III medical device experience preferred
Minimum 2 years’ prior management and positive mentorship experience is preferred
Medical device software engineering background or experience is preferred.
Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions, such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, etc.
Ability to outline sound regulatory strategy in alignment with regulations and business priorities
Think analytically with excellent problem-solving skills
Effectively negotiate internally and externally with regulatory agencies
Clear and effective verbal and written communication skills with diverse audiences and personnel
Knowledge of business functions and cross group dependencies/ relationships.
Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met
Leadership of functional groups in the development of relevant data to complete a regulatory submission
Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
Able to effectively and positively lead direct reports while demonstrating flexibility to changing environments.
Proficient in MS Word, Excel, Adobe and Power Point