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VP of Regulatory Affairs

Company: Medical Devices / Equipment, Redmond, WA or Bartle
Location: Redmond
Posted on: January 13, 2018

Job Description:

The purpose of the RA/QA Vice President is to provide leadership and management to the Regulatory Affairs function in Company of the Americas. This role will be responsible for the global regulatory filings of all products where the Legal Manufacture exists in the Americas region. Further, they will serve as a consulting role for where the Legal Manufacture is an Company that exists outside of the Americas.

Company embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled

At Company, we are True to You! Job Duties: * Establishing and Executing a Regulatory Strategy for product Manufactured by OSTA and sold WW. Represent Regulatory Affairs on project teams and provides regulatory guidance regarding submission and clearance strategy.

* Act as a consultant for product manufactured by Company in other regions but sold in the Americas. Represent Regulatory Affairs on project teams and provides regulatory guidance regarding submission and clearance/approval strategy.

* Authoring and maintaining regulatory filings for product manufactured by OSTA including 510k, IDE/PMA, and HDE products. Review, revise, compile, submit and clear regulatory submissions for Company branded products manufactured outside the U.S.

* Manage the Label Control and Advertising and Promotion review process.

* Monitor the Regulatory Environment in the Americas and advice the company on changing regulation in the region. Interpret regulations, guidance/policies; communicate existing policies and changes in the regulatory environment to RA staff outside of the Americas.

* Serve as spokesperson for OCA in the Americas region on Regulations either through industry groups or serving on Regulator Advisory Panels.

* Serve as most responsible Quality/Regulatory contact on any Regulatory Mandated Clinical Study.

* Support the Clinical Affairs department for FDA regulated clinical studies, assuring that all regulatory submissions and documentation comply with U.S. regulations.

* Demonstrates the ability to form and motivate cross functional groups to accomplish project related objectives.

* Develop the next generation of Quality thought leaders.

* Perform all other essential duties as required Job Requirements: (ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)

* Bachelor's degree is required, Master's degree is preferred, .

* Minimum 10 years experience in Medical Device Industry is required.

* Minimum 5 years experience in a position of leading and developing people leaders and teams is required.

* Expert understanding in the writing of regulatory submissions is essential.

* Expert understanding in the writing of Tech Files is desired.

* Strong people leader with experience raising the skill level of the organization is preferred.

* Must possess the ability to work with Business Partners in other Functions to achieve business results.

* Business principles working in a regulated environment is desired.

* Must focus on the customer.

* Some Travel will be required but no more than 25%.

Keywords: Medical Devices / Equipment, Redmond, WA or Bartle, Seattle, VP of Regulatory Affairs, Executive, Redmond, Washington

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