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10 days old

Remote Regulatory Affairs Specialist

Kelly Services
Madison, WI 53786 Work Remotely
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Remote** **Regulatory Affairs** **Specialist** .


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Remote** **Regulatory Affairs** **Specialist**


**Pay: $46.03 50.73 per hour depending on experience**


**Position Summary** :

Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives for client K-C business units, while ensuring compliance with US FDA and Health Canada Class II medical devices. Provide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global markets in order to meet launch timelines.



**Expectations** :

Develop and implement US FDA and Health Canada medical device specific regulatory strategies in support of business objectives.

Monitor the development of regulatory initiatives and communicate potential business impact to business and QRC senior management.

Provide interpretation on and training of domestic and international regulatory requirements to the appropriate business and QRC team members.

Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective actions.



**Scope** :

The incumbent is responsible for establishing and maintaining regulatory strategies designed to effectively and efficiently support business objectives.

This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business(es).


**The main challenges of the position are** :

Understanding the various domestic and international business needs.

Understanding and interpreting domestic and international regulations relative to new technology, and product development.

Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the company business units.

Have the insight to problem-solve proactively on regulatory and associated quality issues.

Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing and competitive access.

Comply with K-C policies, internal controls and global regulations.



**Qualifications/Education/Experience Required** :

A broad technical background is required; a bachelors degree in a major scientific discipline and 7 to 10 years of relevant technical experience, including FDA and Health Canada regulations for medica devices. Must possess an understanding of US FDA and Health Pre-market Notification and clearance process, product development process including product design/formulation, manufacturing, engineering, marketing and legal matters obtained through experience and/or advanced education and the implications on a global launch of a given product


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-03 Expires: 2021-06-03

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Remote Regulatory Affairs Specialist

Kelly Services
Madison, WI 53786

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