Senior Regulatory Affairs Specialist - Reducer International
Description
Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life.
Position Overview
The Sr. Regulatory Affairs Specialist is an individual contributor who works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical, 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 EU and International geographies. 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.
Essential 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 international regulatory authorities (to include competent authorities and notified bodies) accurately and on time.
Coordinate with in-country representatives and distributors for registrations and filings as appropriate.
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 manufacturing 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 files and tracking databases as required.
Evaluate import/export requirements.
Identify emerging issues.
Provide other country-specific regulatory support.
Effectively and accurately 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 a regulatory submission.
Other duties as assigned.
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, approximately 2-3 times a year.
Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
Experience with pre- and post-market medical device submissions such as EU Technical Files and Design Dossiers. Experience with other international filings and MDR-specific filing a plus.
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.
Class III medical device; technical, scientific or engineering background or experience is preferred.
Proficiency in MS Word, Excel, Adobe and Power Point.
San Francisco Bay Area (SFBA) Market Range: $101,000 - $141,500
All Other US Locations (Outside of SFBA): $88,000 - $123,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave 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