20 days old

Regulatory Affairs Specialist, San Diego, CA

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

**Position Type:** Direct Hire

**Shift:** 1st shift; Monday- Friday

**Key Accountabilities**

+ Leads regulatory related projects to successful outcomes. Includes collaboration with other project team members, managing project plans and ensuring timely deliverables. Prepares and presents project updates and conclusions.

+ As a regulatory expert, serves as a subject matter expert in responding to questions and issues from junior members of the team and other departments.

+ Provides training to new and developing department staff; provides training on a variety of regulatory topics to other Inova staff, as needed.

+ Represents the department on projects lead by other departments, as needed.

+ Prepares submissions to EU regulatory entities to obtain CE Mark. Creates and maintains product EU Technical Files and regulatory database(s).

+ Prepares, collects and/or coordinates information and prepares regulatory documentation for submission to international regulatory agencies, EU Authorized Representative, Werfen affiliates and Inova distributors.

+ Reviews 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.

+ Participates and facilitates the Post Market Surveillance Program plan, schedule, report and maintenance

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

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

+ Prepares and maintains Unique Device Identification (UDI) database for appropriate geographies.

+ Provides support in 510(k) submissions, as needed.

+ Prepares and coordinates documentation necessary to obtain/renew import/export licenses and related permits.

+ Complies with applicable Inova standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.

+ Reflects the values of Werfen and Inova in the quality of work and in working relationships.

+ Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

**Minimum Education, Experience, Skills/Knowledge Education:**

+ Bachelor's degree B.A. or B.S. or equivalent in the biological sciences or related sciences required.

+ Minimum of 5 years of relevant experience within Regulatory Affairs discipline required, preferably in the vitro diagnostics industry.

+ Experience and competency in Class II device required.

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

+ Experience in creating and maintaining EU Technical files required.

+ Experience in preparing 510(k) submissions preferred.

+ Demonstrated experience at successful written and verbal communication with a variety of stakeholders.

+ Proven track record of successfully analyzing complex situations, applying critical thinking skills to resolve issues and complete projects.

+ Competent in Microsoft tools like Excel, Word, PowerPoint required.

+ Knowledge of US and International medical device regulatory requirements required.

**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656, Email at, or schedule a time to connect directly follow the link:** ****

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-03-31 Expires: 2021-05-01

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Regulatory Affairs Specialist, San Diego, CA

Kelly Services
San Diego, CA 92108

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