7 days old

Sr. Regulatory Affairs Specialist

Kelly Services
Dallas, TX 75219
**Sr. Regulatory Affairs Specialist III Austin, TX**

**Direct Hire!**

Kelly Science & Clinical is currently recruiting for a Regulatory Affairs Specialist III for a medical device company developing technology and early oral cancer detection testing. The integrated management system assists clinicians in managing patient test data and reporting over time. Clinicians can now easily identify patients that may be high risk to have, or develop, oral cancer at the earliest possible time and refer these patients to a specialist for appropriate treatment.

**Job Responsibilities:**

+ Perform the coordination and preparation of document packages for regulatory submissions for oral cancer detection products as well as internal audits and inspections.

+ Compile all materials required for device submissions, license renewal and annual registrations.

+ Provide regulatory guidance to the organization as part of the role as the assigned regulatory representative for a product line or development project.

+ Support regulatory strategy plans to identify actions required for market access.

+ Assess change impacts to products and processes and initiate regulatory actions to maintain market access.

+ Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.

+ Monitor and improve tracking/control systems.

+ Keep abreast of regulatory procedures and changes in target markets.

+ May direct interaction with regulatory agencies on defined matters.

+ May recommend strategies for earliest possible market access including clinical trials.

**Education, Knowledge and Experience:**

+ Bachelor's or advanced degree in an engineering or science major and 5+ years of related experience with medical devices

+ Experience in leading the development, writing and submittal of medical device regulatory submissions in the US, Canada and the EU.

+ Working knowledge of ISO 13485, 60601, 62304, 21 CFR 820, EU IVDR.

+ Ability to work independently as an individual contributor and in a team environment.

+ Experience with sterile devices

+ Experience with LFD ( lateral flow devices) is a plus

+ Relocation Assistance

+ Direct Hire Opportunity!

+ Full line of Benefits/Competitive Salary

**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: 2021-10-11 Expires: 2021-11-11

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Sr. Regulatory Affairs Specialist

Kelly Services
Dallas, TX 75219

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