Education/Training, Nutritional/Natural Health Products, Quality/Risk Management, Regulatory Compliance
4 Year Degree
The primary responsibility of this position is to function as the regulatory affairs on-site go-to for the educational program. Our candidate would directly report to the Sr. Manager, Regulatory Affairs and will act as the primary internal Regulatory Affairs representative in the establishment and maintenance of educational programs and initiatives for Metagenics Institute, a trusted, peer-to-peer, evidence-based educational resource for nutrition and personalized medicine.
What you'll do:
Under the guidance of Sr. Manager, Regulatory Affairs, assess and provide regulatory direction to internal stakeholders on execution of educational program strategies.
Collaborate with internal stakeholders to maintain compliance throughout execution of all educational activities and initiatives, perform detailed review during development of all educational materials and media (including but not limited to websites, videos, emails, webinars, science reviews, whitepapers, and educational presentations) and set appropriate guidelines for use.
Remain accountable for ensuring purity and accuracy of educational content and delivery of such content, in collaboration with Medical Affairs and other stakeholders.
Proactively identify regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
You'll love this job if you are:
A strong communicator and collaborator and work effectively with all members of the organization, from individual contributors to top execs
Highly analytical and strategic. Your problem solving skills are unparalleled
You always maintain a friendly disposition — even (and especially) under pressure
Quick on your feet! When problems arise, you reliably produce responses and solutions
What you'll need:
Experience / Training / Education
Bachelor's Degree in Nutrition, Chemistry, Biochemistry, Regulatory Affairs or related field
Advanced degree (MBA, Master's) preferred
At least 2 years of manager-level experience
5+ years' experience in Regulatory affairs in the dietary supplement, medical device, or pharmaceutical industry
High scientific and regulatory literacy to execute on the review of complex educational materials primarily related to dietary and lifestyle interventions
Solid understanding and application of regulatory concepts including (but not limited to) those relating to FDA, FTC, HIPAA, etc.
Demonstrates a high level of regulatory orientation as a value-adding partner to Education, providing constructive input to educational strategies and operational plans
Regulatory terrain as relates to FDA, FTC, Patient Privacy, and Healthcare Compliance
Lifestyle and functional medicine
Advanced clinical nutrition science
Demonstrates high ethical standards coupled with critical problem-solving skills to formulate creative and compliant solutions.
Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
Detail-oriented with high proficiency in MS Office Suite, Outlook & Internet applications
Strong verbal and written communication skills (including analysis, interpretation, & reasoning)
Ability to collaborate with all layers of organization - from peers and senior management
Internal Number: 3223
Metagenics is a global lifestyle medicine company, offering products and programs exclusively to health care practitioners. For over 30 years, we have been driven by a scientific concept: How the right nutrition can help people realize their best health possible. We don't compromise on safety, efficacy, or quality - to make sure that we deliver the best results possible. Time after time. Bottle after bottle. We carefully monitor all products to assure purity and safety, from formulation and ingredient selection all the way to the final product. We offer more educational support for health care professionals than anyone else in our field - keeping them in touch with the latest research and nutritional approaches to help manage today’s most common illnesses. Metagenics is dedicated to helping people live a happier, healthier life by realizing their genetic potential.