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Senior Regulatory Affairs Specialist - International

Company: Endologix, Inc.
Location: Irvine
Posted on: September 12, 2019

Job Description:

*

SENIOR REGULATORY AFFAIRS SPECIALIST - INTERNATIONAL

Job ID

2019-2113

Location

US-CA-Irvine

Category

Regulatory

OVERVIEW

Endologix develops and manufactures innovative endovascular aneurysm repair solutions. We are a fast-moving, high energy organization. Our Employees benefit from 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.



This position is responsible for the preparation and maintenance of international regulatory filings to meet corporate objectives and for the timely completion of other assigned activities related to regulatory support activities worldwide.

RESPONSIBILITIES

* Prepare high quality international filings/registrations to established timelines

* Coordinate with international contacts on all regulatory activity (i.e. Product changes and regulatory notification / approval requirements)

* Develop and implement regulatory strategies

* Update International departmental procedures as required

* Ensure applicable international regulations related are met

* Support and work with cross functional departments

* Maintain up-to-date knowledge on international and domestic regulatory requirements

* Process Certificate to Foreign Government or Export Certificate for Global registration as required

* Perform other duties as assigned by supervisor

QUALIFICATIONS

* Extensive knowledge of global medical device regulations

* Experience preparing international regulatory submissions

* Ability to interpret regulatory standards and guidance, providing a summary to leadership

* Ability to work in a fast-paced, technically challenging environment where drive is critical to success

* Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities

* Effective interpersonal skills/diplomacy and problem solving techniques

* Experience in negotiating to achieve goals and mutually agreeable time lines

* Excellent applied thinking and technical writing skills

* Strong oral and written communication and organization skills required

* Product development team experience (preferred)

* Experience with US Class III cardiovascular (preferred)

* Bilingual (Chinese) (preferred)

Education:

* Bachelor s degree in a scientific discipline or equivalent

Experience:

* Minimum of 5 years in International Regulatory Affairs, or equivalent.

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.



If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800.

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Endologix, Inc., Irvine , Senior Regulatory Affairs Specialist - International, Other , Irvine, California

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