Endologix, Inc

Principle Regulatory Affairs Specialist

Job ID
2018-1817
Location
US-CA-Irvine
Category
Regulatory

Overview

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

 

The Principle Regulatory Affairs Specialist represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. The position also assists with the training of less senior Regulatory Affairs personnel and provides leadership in meeting and defining departmental objectives, while giving work direction on projects of large scale and complexity. Activities are largely self-managed.

 

Responsibilities

 

Prepare regulatory strategies/plans and worldwide compliance requirements for specific projects. Provide leadership and serve as primary regulatory contact to teams for issues and questions on complex products/projects; Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidance’s and ensure effective communication to the project teams and management; Provide regulatory related business and product information to international regulatory partners to enable development of strategies and requirements, and communicates that information to business teams. Provide product and test information to support international submissions; Negotiate directly with the FDA and, where appropriate, other regulatory agencies on all projects/products, as required; Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate; Works on unusually complex technical problems as required, and provides highly innovative and ingenious solutions.  Applies advanced regulatory principles, theories, and concepts.  Contributes to the development of new principles and concepts; Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product/manufacturing process changes and submissions for changes requiring government approval; Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication; and Actively involved with management in setting broad business strategies.

 

 

Qualifications

Qualifications

Bachelor’s degree (or foreign equivalent) in Biotechnology, Biomedical Engineering, or related academic field. plus 9 years experience in the job offered or a closely related occupation. (OR) Master’s degree in Biotechnology, Biomedical Engineering, or related field and 7 years of progressively responsible experience in job offered or a related occupation

 

Special Requirements:

Experience with the following:

  • Demonstrated proficiency with regulatory planning/strategy, submission preparation and multiple geography worldwide regulatory requirements.
  • Extensive knowledge of global medical device regulations and product development processes.
  • Comprehensive knowledge of quality systems and relationship to business.
  • Experience in developing and communicating global regulatory strategies.
  • Provide leadership, creativity, and business acumen when interpreting regulatory standards and guidances

 

*Ability to travel up to 30% to various unanticipated project sites based on project needs. *Employer will accept any suitable combination of education, training, or experience.

 

Endologix, Inc. is an equal opportunity employer.

 

How to apply: Qualified applicants please send resume to:

Endologix, Inc.

ATTN: Catherine Choi

2 Musick, Irvine, CA 92618

**Must reference JOB CODE#: JL-01 when applying.

 

EOE M/F/D/V

It is the policy of Endologix, Inc. to afford full equal employment opportunity to qualified employees and applicants, regardless of their race, color, religion, sex, national origin, age, physical or mental handicaps, military or veteran status, sexual preference, or any other protected condition or characteristic in conformity with all applicable federal, state and local laws and regulations.

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