SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Chief Regulatory Officer

Company: Eitan Medical
Location: San Diego
Posted on: February 24, 2021

Job Description:

We are excited to offer the role of Chief Regulatory Officer (CRO) to be based remotely. This role will be part of the Regulatory Affairs globally at Eitan Group.CRO Responsibilities

  • Implementation of the regulatory strategy, risk management and continuous improvement projects to achieve business objectives.
  • Review and advise on all material FDA and global regulatory submissions/or registration strategies for product approvals or clearances. Review and approval of all FDA, NB requests and other regulatory agency inquiries.
  • Review and advise the management on product risk assessments and global change assessments.
  • Oversee risk management activities that can impact registration or business growth strategies of the business.
  • Build a team with capabilities to support the short-, mid- and long-term goals of the company.
  • Developing regulatory strategies and tactics, including building external partnerships, designed to achieve global product clearances and approvals faster and in compliance with relevant regulations and law. Actively participates on the RA Leadership team and regulatory trade associations operation projects, among other things.
  • Partners with Quality to ensure policies and procedures align with the Eitan Group Quality System.-- Lead and/or facilitate team preparation for regulatory agency/Health Authority meetingsLead and/or facilitate communications with global regulatory agencies
    • Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents.
    • Develop, define and lead internal growth and resourcing strategy for Global Regulatory Affairs within the organization the members of the regulatory affairs teams.Position Requirements:Education:
      • Bachelor of Science Degree in a Life Science or Engineering field is required
      • Advanced degree preferred (MS, PhD, MBA)Requirements:
        • Minimum of 10-15 years of medical device and/or pharmaceutical experience, directly working on regulatory filings required
        • At least 7 years of direct management
        • Recent experience leading meetings with FDA/CDRH for new device products - a Must
        • RAC certified a plus, but not required.-- Global regulatory experience combined with a desire to learn, investigate, and research global regulations, guidance's and industry standards-- Thorough understanding of medical device and combination product associated national regulations, and general knowledge of international regulations. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as subject matter expert in multiple areas-- Strong verbal and written communication skills-- Independently authors written reports/documents for distribution within division.-- Recognizes potential problems and proposes solutions-- Assesses potential impact and/or applicability to other related areas within unit and business.-- Assesses corrective action to assure it prevents recurrence.-- Able to confidently deal with ambiguous issues and provide input towards suitable actions.-- Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.-- Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.-- Manages and monitors multiple complex and diverse projects simultaneously, including projects that involve several functional areas.Special Skills:-- Ability to link regulatory strategy, tactics, and outcomes to business strategy-- Ability to create and sustain a results-oriented culture-- Strong business acumen-- Ability to influence through effective communication, people management, and leadership skills.-- Ability to work independently and proactively-- Ability to work effectively in a cross-functional teamComplexity of Duties:-- Working in a matrix, across organizational boundaries and within ambiguous environments.-- Works on complex issues in a cross-cultural business environment.-- Ability to manage multiple priorities at the same time.-- Must operate with a sense of urgency.-- Ability to travel domestic and internationally as necessary Personality:-- A team player-- Ability to multi-task and work well within a dynamic, fast-paced organization-- Organized, paying attention to the small details

Keywords: Eitan Medical, San Diego , Chief Regulatory Officer, Executive , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Director of Financial Planning & Analysis
Description: SpineZone is looking for a Director of Financial Planning Analysis to help evolve our internal finance function. You will be help the organization develop best practices, key metrics and internal financial (more...)
Company: SpineZone
Location: San Diego
Posted on: 03/6/2021

Health Services Director - Registered Nurse - Relocation Provided to Wenatchee, WA
Description: What does the Health Services Director do The Health Services Director oversees the health services department and ensures resident care needs are met by conducting assessments, developing care plans, (more...)
Company: Prestige Care, Inc.
Location: San Diego
Posted on: 03/6/2021

Financal Force Program Manager - Product Owner Reporting
Description: FinancialForce Program Manager / Product Owner Reporting Location: San Diego, CA or Remote Teradata is building out a team of analytical, problem solving and solution-oriented program managers with (more...)
Company: Teradata
Location: San Diego
Posted on: 03/6/2021


Business Application Manager
Description: We're committed to bringing passion and customer focus to the business. Primary Location:San Diego CAAdditional Job Posting Locations:Bend OR Job Description Summary: PROMOTE TECHNOLOGY AWARENESS, ADOPTION, (more...)
Company: Swinerton
Location: San Diego
Posted on: 03/6/2021

Operations Manager
Description: Professional Contractor Supply PCS is seeking an Operations Manager to manage all warehouse, delivery, and shipping operations at PCS San Diego.Our Operations Manager has a few key responsibilities: (more...)
Company: Professional Contractors Supplies, Inc
Location: San Diego
Posted on: 03/6/2021

Accounts Payable Manager
Description: The ideal candidate will be well organized and comfortable overseeing the AP processing of the organization and its subsidiaries. Responsibilities ul li Accounts Payable Processing
Company: Ledgent
Location: San Diego
Posted on: 03/6/2021

Regional Sales Manager - Federal DOD ( Navy )
Description: Company Description br br At Palo Alto Networks-- everything starts and ends with our mission: br br Being the cybersecurity partner of choice, protecting our digital way of life. br br We (more...)
Company: Palo Alto Networks
Location: San Diego
Posted on: 03/6/2021

Regional Business Manager - Grocery West & Central
Description: Company Description br br Who We Are... br br Based in sunny San Diego, Perfect Snacks is the company behind The Original Refrigerated Protein Bar. Offering a line of products that boast whole (more...)
Company: Perfect Snacks
Location: San Diego
Posted on: 03/6/2021

Cybersecurity Audit Manager
Description: Cybersecurity Audit Manager br Santa Clara, CA, San Diego, CA, Seattle, WA, or Remote, US br br This position reports to:--Sr. Manager, Cybersecurity IT Audit ServiceNow is changing the way people (more...)
Company: ServiceNow
Location: San Diego
Posted on: 03/6/2021

Clinical Program Director
Description: Clinical Program Director br br JOB DESCRIPTION: br The Clinical Program Director is responsible for the overall operations and supervision of AMFM Healthcare's core Behavioral Health Treatment (more...)
Company: AMFM Healthcare
Location: Carlsbad
Posted on: 03/6/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds