Shockwave Medical, Inc.
Principal Regulatory Affairs Specialist
Shockwave Medical, Inc., Santa Clara, California, us, 95053
Regulatory AffairsHybrid Remote , Santa Clara,CADescription
Position OverviewThe Principal 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). The Principal Regulatory Affairs Specialist 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, works independently with minimal oversight, acts as a decision-maker on regulatory issues, assures that registration/renewal and other deadlines are met, and supports new product development, as assigned.Essential Job FunctionsCollaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational unitsDevelop regulatory policies, processes and SOPs and may train key personnel on themDevelop regulatory strategies and update strategy based upon regulatory changesDetermine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholdersProvide input and technical guidance on regulatory requirements to product development and operations teamsWork 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)Review and approve R&D, quality, preclinical and clinical documentation for submission filingIn collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US, as assigned (e.g., EU, Canada, Australia, Japan, etc.)Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvalsEvaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirementsOversee the process for preparation and maintaining annual licenses, registrations/listings for assigned geographiesSupport product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulationProvide regulatory input for product recalls and recall communicationsReview and approve advertising and promotional materials to ensure regulatory complianceEvaluate import/export requirementsIdentify emerging issuesProvide other country specific regulatory supportEffectively and accurately write and edit technical documentsPlan and conduct meetings, create project plans and timelines, and manage projectsExercise good and ethical judgment within policy and regulationsPerform multiple tasks concurrently with accuracyProvide guidance to functional groups in the development of relevant data to complete a regulatory submissionOther duties as assignedRequirementsTypically 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.Think analytically with good 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.Leadership of functional groups in the development of relevant data to complete a regulatory submission.Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.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, Excel and Power Point required.San Francisco Bay Area (SFBA) Market Range: $121,000 - $151,000All Other US Locations (Outside of SFBA): $102,000 - $128,000Exact compensation may vary based on skills, experience, and location.BenefitsShockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits : Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks : ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
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Position OverviewThe Principal 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). The Principal Regulatory Affairs Specialist 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, works independently with minimal oversight, acts as a decision-maker on regulatory issues, assures that registration/renewal and other deadlines are met, and supports new product development, as assigned.Essential Job FunctionsCollaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational unitsDevelop regulatory policies, processes and SOPs and may train key personnel on themDevelop regulatory strategies and update strategy based upon regulatory changesDetermine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholdersProvide input and technical guidance on regulatory requirements to product development and operations teamsWork 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)Review and approve R&D, quality, preclinical and clinical documentation for submission filingIn collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US, as assigned (e.g., EU, Canada, Australia, Japan, etc.)Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvalsEvaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirementsOversee the process for preparation and maintaining annual licenses, registrations/listings for assigned geographiesSupport product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulationProvide regulatory input for product recalls and recall communicationsReview and approve advertising and promotional materials to ensure regulatory complianceEvaluate import/export requirementsIdentify emerging issuesProvide other country specific regulatory supportEffectively and accurately write and edit technical documentsPlan and conduct meetings, create project plans and timelines, and manage projectsExercise good and ethical judgment within policy and regulationsPerform multiple tasks concurrently with accuracyProvide guidance to functional groups in the development of relevant data to complete a regulatory submissionOther duties as assignedRequirementsTypically 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.Think analytically with good 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.Leadership of functional groups in the development of relevant data to complete a regulatory submission.Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.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, Excel and Power Point required.San Francisco Bay Area (SFBA) Market Range: $121,000 - $151,000All Other US Locations (Outside of SFBA): $102,000 - $128,000Exact compensation may vary based on skills, experience, and location.BenefitsShockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits : Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks : ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
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