JobWatch

12 days old

Contract Regulatory Affairs Specialist - Remote

Kelly Services
Cincinnati, OH 45217
**Contract Regulatory Affairs Specialist - Remote**


Kelly is hiring a contract RA Specialist to join our Kelly FSP (Functional Service Provider) division and support a well known sponsor client. This role is providing support until end of 2021 within the Regulatory Affairs division. The opportunity offers our enhanced benefit options including medical, dental, vision plans, accrued paid time off and paid holidays.


**OVERALL RESPONSIBILITIES:**


The Regulatory Affairs Specialist provides independent regulatory guidance to cross-functional teams in strategic planning, pre-marketing, and related submissions to support modified product launches. Under minimal supervision, the individual manages the submission of licenses and authorizations for the maintenance of existing products, new products, international registrations, and dossiers. The RA Specialist helps to define data and information needed for regulatory approvals in conjunction with cross-functional product teams. The role assists in the development of best practices for Regulatory Affairs processes.


**POSITION DUTIES & RESPONSIBILITIES:**


+ Ensures compliance with regulatory agency regulations and interpretations.

+ Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

+ Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

+ Provides solutions to a variety of problems of moderate scope and complexity.

+ Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates

+ Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance

+ Provides regulatory guidance to product development teams and responds to product information requests

+ Assists in the development of best practices for Regulatory Affairs processes

+ Represents Regulatory Affairs on cross-functional project teams


**Functional and Technical Competencies** **:**


+ Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides Regulatory input into product recall strategies).

+ Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.

+ Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.

+ Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables.

+ Makes decisions with guidance in ambiguous or unclear situations.


**Leadership Competencies:**


+ Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels

+ Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, to influence external stakeholders and promote Regulatory perspectives

+ Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions

+ Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances


**EDUCATION & EXPERIENCE REQUIREMENTS:**


+ Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration

+ Must have at least 2-4 years of Regulatory Affairs experience in the medical device industry.

+ Must have working knowledge of U.S., E.U., and International Regulatory requirements and be able to apply this knowledge to ensure that all projects maintain compliance to worldwide regulatory requirements.

+ Must have previous experience with document management systems and change control systems.

+ Must be able to work independently, utilizing research and problem-solving skills, and the willingness to learn new skills.

+ Must have excellent Global written, verbal communication and presentation skills.

+ Must be able to communicate clearly, succinctly, and effectively.

+ Must have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.

+ Must be able to work in a timeline-driven environment.


**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. 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)
Posted: 2021-02-12 Expires: 2021-03-15

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Contract Regulatory Affairs Specialist - Remote

Kelly Services
Cincinnati, OH 45217

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast