Regulatory Affairs Specialist - Entry Level

---

Job description

**Kelly Services is actively recruiting for an Entry-Level Regulatory Affairs Specialist for a Direct Hire opportunity in Lakewood, Colorado.**

This opportunity is with a medical device company and related products that are used to collect, separate, manufacture and process various components of blood and cells. With their innovative technologies and service offerings, they touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve.

**JOB SUMMARY**

Working under limited supervision, assists in fulfilling Regulatory compliance requirements for more than one product/project by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals, or biologics.

**ESSENTIAL DUTIES**

+ Expert in regulations in order to author entire Regulatory dossiers and identify and suggest potential strategies that can be used to address the gaps.

+ Identifies and defines contents for Regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.

+ Provides Regulatory support to life cycle project teams at any point in the development process.

+ Interacts with and/or directs others in interacting with Regulatory and Certification authorities.

+ Identifies the need for, prepares, and conducts Regulatory related training for the business.

+ Represents functional area within specific business area to provide guidance and recommendations for issues that may arise. May require approvals from management.

+ Assumes major responsibility for one or more major Regulatory Affairs areas based on past experience and a broad base of knowledge and understanding of regulatory requirements Identify problems and significantly improve, change or adapt existing methods and techniques drawing from personal experiences and feedback.

+ Reviews device labeling, advertising materials and product manufacturing changes for compliance with global regulations; analyses and recommends appropriate changes.

+ Advises business management of regulatory and certification issues in a pro-active manner.

+ Exercises considerable judgment in determining approach and then researches, prepares, and submits required regulatory documents including those in response to documents issued by regulatory authorities. Responsibility includes both preparation of these documents in compliance with U.S. and international regulatory authorities and providing guidance to Regulatory staff in the preparation of them.

+ Reviews submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story.

+ Collaborates with individuals at different levels and develops or is responsible for the development of either solutions to problems of limited complexity that affect diverse functional areas, or solutions to problems of moderate complexity that may affect a few functional areas.

+ Executes policies at direction of supervisor and makes recommendations for improvements within the organization.

**Minimum Requirements for the Senior Regulatory Affiars Specialist opportunity includes:**

+ BS or MS degree in Regulatory Affairs, Physical/Biological Sciences or Engineering required.

+ Ideal candidate will have had some experience to Regulatory Affairs or Quality Assurance within Medical Devices (industry and/or education)

+ Willing to train ideal candidate.

**\#TJP2021_SPEC**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ()