Regulatory Affairs Specialist

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This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$80.00/hr - $100.00/hr

Kelly Science & Clinical is seeking a Regulatory Specialist for our client, a leading medical device company based in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

REMOTE role

Schedule:

Monday through Friday 8am to 5pm (eastern time zone- highly preferred)

Length of assignment: 6 months

Responsibilities

• Responsible for ensuring all promotional, educational, and training materials used in conjunction with the promotion of products conform to all applicable laws and regulations for US and Canada.
• Provides regulatory review and approval of advertising and promotional materials, new campaigns and launch strategies.
• Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
• Monitors FDA and FTC activity (as appropriate) including enforcement actions, guidance documents, etc. to analyze impact on Company products and communicates risk to Promotional Review Committee (PRC).
• Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies.
• Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct competitor-to-competitor challenges
• Continually assesses the advertising and promotion related process to enhance efficiencies, compliance and assist with ongoing regulatory training related to products.
• Works closely with the Regulatory Affairs labeling group in order to assess and determine the impact of proposed labeling changes on product promotion.

QUALIFICATIONS/ TRAINING

• Bachelor’s degree preferred or equivalent Minimum of 5 years in Regulatory Affairs or relevant experience in a regulated environment. 5+ years of ad/promo experience relevant to medical devices.
• Strong organizational skills and excellent in managing multiple priorities
• Excellent communication skills (oral and written)
• Computer Literacy – Microsoft Package including Word, Excel, and Outlook;
  Adobe Acrobat and Veeva
  • Entrepreneurship and focus on customer needs;
  Good business acumen and sense of urgency
• Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy & increase probability of regulatory success
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data
• Knowledge of current and emerging issues and trends
• Strong interpersonal skills with the ability to influence others in a positive and effective manner, without authority
• Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines
• What happens next
• Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
• Helping you discover what’s next in your career is what we’re all about,
• #P1

• Seniority level Associate

• Employment type
  
  Full-time

• Job function Research
• Industries Medical Equipment Manufacturing

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