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Regulatory Affairs Specialist I
3 weeks ago
Join Ortho Molecular Products, Inc. and play a key role in ensuring compliance and quality in every product we deliver. If you're passionate about regulatory excellence and thrive in a science-driven, collaborative environment, we'd love to hear from you.
What To Expect:
- Assist in maintaining the company's regulatory documentation in compliance with state, federal, and international regulations.
- Ensures a state of control for executed and/or master documents within the requirements of applicable regulations and industry standards.
- Coordinates the maintenance of regulatory documentation such as FDA Food Facility Registration, product databases, and more.
- Initiate compliance reviews and approvals of new and revised literature.
- Assist in maintaining appropriate label claims and statements.
- Coordinate the day-to-day operations of initiation, review, follow up, completion and retention of controlled documents to maintain regulatory compliance.
- Monitor regulatory trends and industry standards.
- Draft, revise, and Review Standard Operating Procedures for the controlled documents and record system.
What You Will Contribute:
- Bachelor's degree in related fields (Health Science, Regulatory/Legal or Food/Nutrition Preferred)
- 1-2 years of related experience (Food Science, Nutrition, Legal Studies, Regulatory Affairs, Life Sciences)
- TGA, European Union (EU), and Health Canada experience preferred.
- Experience in a cGMP FDA regulated manufacturing facility preferred.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
- Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- $28 - $33 per hour depending on experience and qualifications
- Bonus Program
- Health, HSA, Dental, and Vision Insurance: Comprehensive coverage to meet your needs.
- Life Insurance (company provided): Ensuring peace of mind for you and your loved ones.
- 401(k) Plan: With company matching to help you plan for the future.
- Health Savings Account (HSA): With company contributions to support your healthcare expenses.
- Paid Time Off: Start with 15 days of PTO annually.
- Paid Holidays: Enjoy time off for recognized holidays.
- On-Site Wellness Meals: Company-paid meals to support your health.
- Gym Membership Reimbursement: Encouraging your fitness and well-being.
- Employee Assistance Program (EAP): Access to confidential support services.
- Voluntary Benefits: Options including short-term disability, life insurance (whole/term), hospital indemnity, critical illness, and accident expense coverage.
- Growth and Development Opportunities: Access to company university and tuition reimbursement programs.
- On-Staff Health Coach: Personalized coaching available one-on-one or in groups.
- Health and Wellness Initiatives: Participate in walking challenges, weight loss programs, health risk assessments, and more
Why Work at Ortho Molecular Products:
Our healthcare system faces significant challenges, with issues like complexity and inefficiency. At Ortho Molecular Products, our vision is to help transform the practice of medicine. We work tirelessly to assist healthcare providers in adopting improved solutions for health issues, integrating lifestyle medicine and evidence-based nutritional therapies that enhance patient outcomes. Our commitment involves crafting scientifically grounded products and pioneering innovative clinical initiatives tailored to support doctors in supporting their patients' recovery and well-being.
We are looking for people who align with our mission and want to invest their lifework and passion into transforming the practice of medicine. Our team is purpose-driven, values-based, and service-focused. We are looking for likeminded people who want to join the movement that is changing the way healthcare is being delivered.
Ortho Molecular Products is an Equal Opportunity Employer.
Ortho Molecular Products participates in E-Verify+ to verify Employment Eligibility.
Applicants must be legally authorized to work for ANY employer in the US.
Ortho Molecular Products will use E-Verify where required.
We invite you to explore the Ortho website to learn about our career opportunities and apply (www.orthomolecularproducts.com).
Join us in our mission to revolutionize healthcare and empower clinicians to make a difference
