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Full-Time

Staff/Principal Regulatory Affairs Specialist

Confirmed live in the last 24 hours

ReCor Medical

ReCor Medical

201-500 employees

Ultrasound renal denervation technology provider

Hardware

Compensation Overview

$142.8k - $192.4kAnnually

Expert

Palo Alto, CA, USA

Category
Risk & Compliance
Legal & Compliance
Required Skills
Communications
Requirements
  • Minimum of a Bachelors’ degree preferably in life sciences and/or biomedical engineering. Advanced degree preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Minimum of 10 years’ experience in regulatory within medical device industry
  • Minimum of 5 years' experience with CEP, CER, PMCF
  • Prior experience with US IDE submissions, CER, PMS, PMCF
  • Experience/knowledge of MDR requirements and Clinical evaluation requirements
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight
  • Experience with medical device hardware and software requirements and software regulations
  • Demonstrated ability to work well in dynamic and cross functional team environment
  • Demonstrated collaboration and leadership skills in team setting
  • Solid understanding of design control and change control
  • Experience reviewing design specifications and other technical documents
  • Excellent interpersonal and communication skills, both oral and written
  • Ability to identify risk areas and escalate issues as appropriate
  • Self-motivated with excellent time management skills
  • Strong team player; willing to work collaboratively
Responsibilities
  • Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports, Periodic Safety Update Reports, Post approval study reports in alignment with applicable clinical and regulatory standards and business needs
  • Represent regulatory in clinical program teams and communicate regulatory strategies
  • Review and approve internal engineering documentation and change orders
  • Provide support to currently marketed products as necessary including review of labeling, promotional material, product changes and documentation for changes
  • Lead product related regulatory compliance activities, including WEEE, Prop 65, REACH and RoHS
  • Develops and implements processes involved with maintaining annual licenses, registrations and listings. Ensures both regulatory compliance needs, and business needs are met
  • Lead the development of internal procedures, templates, style guides and departmental continuous improvement initiatives as they relate to the function
  • Interprets new or existing regulatory requirements (US, EU, OUS) as they relate to the product portfolio and regulatory and quality system procedures
  • Complies with U.S. Food and Drug Administration (FDA), EU and international regulations, other regulatory requirements, company policies, and governing procedures and processes
  • Keep abreast of changes in agency regulations and requirements, and trains stakeholders accordingly
  • Assist in organizational and planning skills to manage complex regulatory projects within timelines and budgets
  • Provide business and product information to international regulatory staff to enable development of strategies and requirements for global commercialization
  • Continuously evaluate, recommend, and implement improvements as needed
  • Willingness to perform other responsibilities as assigned

The Paradise™ Ultrasound Renal Denervation (uRDN) System by ReCor Medical utilizes ultrasound energy delivered by a balloon catheter to target overactive renal nerves, potentially reducing blood pressure and medication dependency through a minimally-invasive procedure.

Company Stage

Series D

Total Funding

$37.9M

Headquarters

Palo Alto, California

Founded

2009

Growth & Insights
Headcount

6 month growth

14%

1 year growth

48%

2 year growth

94%