This job has expired

Sr. Principal Regulatory Affairs Specialist

Employer
Shockwave Medical, Inc.
Location
Santa Clara County, California, US
Salary
Competitive
Closing date
Jan 15, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
You need to sign in or create an account to save a job.
Description

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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. 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 Sr. 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 in the assigned geographies outside the US or the EU. 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 Functions
  • Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units
  • Develop regulatory policies, processes and SOPs and may train key personnel on them
  • Develop regulatory strategies and update strategy based upon regulatory changes
  • Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders
  • Provide input and technical guidance on regulatory requirements 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, REACH, 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/or submit regulatory submissions to authorities outside the US or the EU, as assigned (e.g., China, Latin America, Middle East, Asia Pacific, etc.)
  • Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
  • Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
  • Oversee 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
  • Review and approve advertising and promotional materials to ensure regulatory compliance
  • 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
  • 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.
  • 12+ years of regulatory experience in the medical device industry. Class III medical device experience preferred.
  • Strong Mandarin Chinese communication skills (written and oral) 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 (e.g., NMPA, TGA, Health Canada, PMDA, 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.

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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert