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THE PROGRAMRegulatory Affairs is a fast-growing and business critical discipline in need of high-performing regulatory affairs professionals. Network Partners’ Apprentice Program teaches the fundamentals of regulatory affairs in the medical device industry. The program utilizes an accelerated format to rapidly bring early stage regulatory affairs professionals to a significantly more advanced level. Gaining this foundation and knowledge base would take years in a typical work environment.
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networkpartners.com
574.377.7151
network-packaging-partners
@NetworkPartner5
@NetworkPartner5
REGULATORY AFFAIRS APPRENTICE PROGRAM
Network Partners
FOUNDATIONAL DEVELOPMENT
Develop a working knowledge of US and Global medical
product regulations
Understand total product lifecycle regulatory considerations
Learn about regulatory affairs input and requirements in
audit situations
Become familiar with various regulatory submission types,
technical documentation, utilization of standards, design
controls and quality systems
THE JOURNEY STARTS NOW
Learn from top industry professionals and subject
matter experts
Work with multiple clients over a 2-3 year period and build
deeper, more varied experience than traditional entry-
level roles
Advance personal and professional skills in diverse
assignments and locations
Earn competitive compensation and best-in-class benefits
HANDS ON LEARNING
Gain experience with the creation and update of regulatory
submissions and documentation
Engage in simulated exercises to build real-world
knowledge and understanding
Learn directly from industry experts regarding a variety of
regulatory affairs foundational knowledge
Participate in client meetings and gain an appreciation for
Network Partners’ business model
Gain knowledge and build a professional network through
conference participation
BEYOND REGULATORY AFFAIRS
Experience functional areas adjacent to Regulatory Affairs:
Packaging, Labeling, Project Management & Quality Systems
Build business acumen and a strong working knowledge of
common business software tools
Become an ambassador for the Network Partners' brand
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WHAT IT TAKES
We’re seeking hardworking regulatory affairs professionals eager to continue to learn and expand upon their regulatory knowledge in the medical device industry. The ideal candidate embraces a strong work ethic, thrives on a challenge, always gives their best effort, and is a strong brand ambassador.
• Regulations
• Product lifecycle considerations
• Audit situations
• Regulatory submission types, technical documentation, design controls and quality systems
FUNDAMENTALSNetwork Partners’ team of medical device subject matter experts bring their real-world experience and expertise to the Regulatory Affairs Apprentice Program.
• Legislative History
• Regulatory Authorities
• Regulatory Pathways
• Regulatory Strategy
• Pre-market vs. Post-market Requirements
• Communication and Collaboration
• Audit and Enforcement
• Regulatory Intelligence
BUILDING BLOCKS OF REGULATORY AFFAIRS
• Project management overview
• Communication skills for successful business interactions
• Importance of maintaining client relationships
BUSINESS ACUMEN
APPRENTICE TRAINING OVERVIEW
NICHOLAS WERNER
Nicholas leads Network Partners’ Apprentice training program and brings his regulatory affairs experience and knowledge into the classroom. His experience working for the US Food and Drug Administration and within a major medical device manufacturer brings the Apprentices perspectives from both the regulator and the regulated. Nicholas covers the history of medical product regulations, total product lifecycle considerations, the basics on pre-market and post-market requirements, interactions with regulatory authorities, and how to develop appropriate regulatory strategy.
APPRENTICE PROGRAM LEADER AND DIRECTOR OF REGULATORY POLICY & EDUCATION
SUSAN SPEICHER, MS, RAC
Susan has extensive knowledge and experience in many aspects of the medical device industry, including R&D, Regulatory Affairs and Quality Management Systems. She teaches the Apprentices how regulatory strategies impact device development planning and management, how Quality and Regulatory work together with Engineering to meet international regulatory requirements, while utilizing project management and communication skills to lead project teams to success.
DIRECTOR, REGULATORY AFFAIRS
KAREN POLKINGHORNE, MBA
As Network Partners Sales & Marketing leader, Karen teaches the Apprentices about the regulatory affairs industry and some key business elements for becoming a successful regulatory affairs professional. Business topics covered in the program include building a strong business acumen and working knowledge of common business tools, presentation skills, overview of business interactions with manufacturers and tips for successful communications.
Executive Vice President
RATINDER DHAMI, RAC
Ratinder brings a wealth of knowledge in regulatory affairs including medical device, pharmaceutical and combination products. Ratinder trains the interns on the ins and outs of an original PMA submission authoring, cross-functional team input and review process. Post-market Class III submissions discussed include the US RTR, 30-Day PMA Supplements, 180-Day PMA Supplement. Additional training is provided on the pharmaceutical regulatory affairs pathways (US, EU and Canada) and combination product regulations.
DIRECTOR, REGULATORY AFFAIRS
networkpartners.com
574.377.7151
network-packaging-partners
@NetworkPartner5
@NetworkPartner5
MEET THE APPRENTICE TRAINING TEAM
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