Profile Details

Contact

★★★★★

☆☆☆☆☆

USD 200 /hr

★★★★★

☆☆☆☆☆

Hire Elizabeth R.

Australia

USD 200 /hr

REGULATORY AFFAIRS - Medical Device - Biotech - Dietary Supplement - Pharma

Profile Summary

Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Supplement DEMONSTRATED EXPERTISE IN : MEDICAL DEVICES Demonstrated Expertise in the following fields in a contractor capacity for over 5 years as a freelancer - Consulting services in the areas of medical device regulation and prescription including quality systems, clinical trials, TGA product registrations, FDA submissions, CE marking, EU MD Registrations. -ISO13485 AND QMS Gap Analysis and Auditing Specializes in - Class 1 , Class 2 and 510(k) Submissions - OTC and Clinical With market expertise in United States ,Canada ,Australia ( TGA) ,New Zealand United Kingdom ,European Union PRESCRIPTION MEDICINES Demonstrated Expertise in the following fields in a contractor capacity for over 10 years as a freelancer specializing in : - Classification + Registration of Generic , OTC , and Prescriptions ,CTD Module Preparation ,Dossier Review Analysis ,Pre Submission Meetings and Liaison ,GMP Clearance and Licensing ,Post-Market Surveillance & Vigilance ,Advertising and Marketing Compliance Assessment ,Pharmacovigilance DIEATRY SUPPLEMENTS Demonstrated Expertise in the following fields in a contractor capacity for over 10 years as a freelancer - Consulting services in the areas of Dietary Supplements and Food Supplements including GMP, Market Registrations, TGA product registrations, FDA submissions, Formulation Compliance , Label Compliance Quality Assurance , Quality Control and Manufacturing Product Formulation and Regulatory Affairs With market expertise in United States , Canada ( Health Canada),Australia ( TGA) ,New Zealand ( Medsafe),United Kingdom ( MHRA),European Union ( Various Countries),UAE,Ireland RELEVANT QUALIFICTIONS : Regulations of Dietary Supplements and NHP's (FDA/Canada) Regulatory Affairs Certificate : Pharmaceuticals ( US , Canada , EU ) Bachelor of Health Science Complementary Medicine Advanced Diploma Nutritional Medicine Certificate of Pediatric Nutrition. DETAILING MY KEY SERVICES IN : Regulatory Affairs - Cosmetic, Pharmaceutical and Food Supplements and Medical Devices Product Development of tablets , powders, capsules. Cosmetic Formulations - pressed powders , oils , creams Product Registrations ( Both International and Australia) Quality Assurance and GMP Ingredient Sourcing Labelling / Packaging Compliance With over 10 years experience I can help you develop your idea into a full cycle product on the shelf , contact me today for a quote.

Subject Matter Expertise

• ★ Regulatory Affairs
• ★ Product Compliance
• ★ Formulation
• ☆ Biotechnology & Bioengineering
• ☆ Nanobiotechnology
• ☆ Nutrition Science
• ☆ Recipe Formulation
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Product Development
• ☆ Food Law

Services

• Consulting
• Product Development

Consulting Scientific and Technical Consulting

Product Development Formulation

Work Experience

Product Development and Regulatory Compliance

HealthREG Solutions

August 2019 - Present

Education

Certificate of Regulatory Affairs , Dietary Supplements and NHP

RAPS

January 2018 - January 2019

Bachelor of Science ( Nutritional Medicine)

Charles Sturt University

January 2011 - January 2014

Certifications

• Certification details not provided.