Here is your chance to join an innovative and cutting-edge medical device company! The company I am supporting has innovated and launched over 100 products and doesn't plan on slowing down any time soon. This company dominates the market share, and its products can be found in over 50 countries. With a large emphasis on providing honest and real messaging across their products, this company truly cares and invests in their customers.
As a Global Regulatory Specialist, you will be joining an exciting and growing Quality and Regulatory team. They are looking for someone who has knowledge of FDA, GxP and CPSC regulations. In addition, as the Global Regulatory Specialist, you will need to navigate the regulations of global health authorities. In this role you will cultivate the skills to manage regulatory responsibilities connected to product development and aid the manufacturing of the company's medical device, OTC and general use products.
Key Responsibilities:
- Oversee the development and execution of regulatory strategies to ensure timely product launches and manage the preparation and review of international regulatory submissions, including EU MDR Technical Files, Health Canada submissions, and Saudi FDA documentation.
- Act as a representative for international regulatory interests within cross-functional project teams for both new and existing products.
- Review and approve global labeling requirements, including translation materials, claims, and instructions for use (IFU).
- Assess proposed changes for their impact on international regulatory compliance.
- Facilitate clear communication within the Regulatory Affairs/Quality Assurance (RA/QA) group and collaborate with cross-functional teams such as Product Development, Marketing, and Legal.
- Support efforts to maintain ISO 13485 and MDSAP certifications through activities such as internal audits, notified body audits, and SOP compliance.
Qualifications
- A bachelor's degree in Science, Engineering, or Pharmaceutical disciplines.
- Proven experience in international regulatory affairs, including submissions, license renewals, and technical file management.
- At least three years of experience in a medical device, pharmaceutical, or similar industry.
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Meticulous attention to detail and a highly organized approach to tasks.
- Ability to work both independently and collaboratively within teams.
- Results-driven, innovative, and skilled at multitasking.
- Familiarity with 21 CFR 820, ISO 13485, MDSAP, the Medical Devices Directive (93/42/EEC), and the European Medical Device Regulation (2017/745).
