19 days old

Regulatory Affairs Specialist - San Diego, CA

Kelly Services
San Diego, CA 92108
**Regulator Affairs Specialist, San Diego, CA**

**Position Summary:** Responsible for preparing submissions for EU entities for compliance and the maintenance of CE Technical files and database. Participate in Post Market Surveillance program. Prepare and communicate appropriate information to fulfill requirements in support of international product registrations, licensing and/or product submissions. Review labeling and labels for compliance with regulatory requirements. Responsibilities are to be carried out in accordance with established procedures and in accordance with applicable regulations.

**Job Duties and Responsibilities:**

+ Prepare submissions to EU regulatory entities to obtain CE Mark. Create and maintain product EU Technical Files and regulatory database(s).

+ Prepare, collect and/or coordinate information and prepare regulatory documentation for submission to international regulatory agencies, EU Authorized Representative,affiliates and company distributors.

+ Review design history files, device history records and any documentation associated with the development and/or enhancement of product, or requests from appropriate department as needed,for additional technical documentation, to create/maintain Technical Files and support regulatory filings and CE mark submissions and updates.

+ Participate and facilitate the Post Market Surveillance Program plan, schedule, report and maintenance

+ Review product labeling for appropriateness and compliance to regulatory requirements and laws.

+ Review product and process changes for impact on regulatory filings worldwide.

+ Prepare and maintain Unique Device Identification database for appropriate geographies;

+ Provide support in 510(k) submissions,if needed.

+ Prepare and coordinate documentation necessary to obtain/renew import/export licenses and related permits.

+ Other duties as assigned.

**Internal Networking/Key relationships:** Research & Development, Regulatory Management, Quality Management, Document Control, Marketing Product Manager.

**Skills & Capabilities**

+ Strong Communicator

+ Organized

+ Interpersonal Skills

+ Initiative

+ Results Orientation

**Job Requirements:**

+ Bachelor's degree (B.A. or B.S.) or equivalent in the Biological Sciences or related sciences.

+ Minimum of 5 years of relevant experience within Regulatory Affairs Discipline

+ Prefer experience in the vitro diagnostics industry

+ Competent in Class II devices

+ Ability to communicate appropriately, both written and verbally, with internal and external team members.

+ Ability exercising critical thinking, problem solving, and organization talents.

+ Competent in Microsoft tools like Excel, Word, PowerPoint

+ Knowledge of US and International medical device regulatory requirements.

+ Demonstrated experience with ISO and QSRs as applicable to medical devices.

+ Experience in creating and maintaining EU Technical files.

+ Experience in preparing 501(k) submissions.

+ Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-07-29 Expires: 2019-08-29

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Regulatory Affairs Specialist - San Diego, CA

Kelly Services
San Diego, CA 92108

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