THE PROGRAM

Regulatory 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.

FOUNDATIONAL DEVELOPMENT

Working knowledge of US and Global

medical product regulations

Total product lifecycle regulatory

considerations

Regulatory affairs input and

requirements in audit situations

Various regulatory submission types,

technical documentation, utilization

of standards, design controls and

quality systems

HANDS ON LEARNING

Study of regulatory submissions and

documentation

Real-world knowledge and understanding

through simulated exercises

Exposure to client meetings and business

engagements

Trade show and event participation, gaining

current industry knowledge and building a

professional network

BEYOND REGULATORY AFFAIRS

Exposure to 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

Successful professionals soft skills training:

verbal and written communication, business

etiquette, organizational understanding

EMPLOYER BENEFITS

Right amount of experience at the right price

Flexible contract assignments

Weekly SME support and mentoring to help

move projects forward

Customized training options to meet client’s

unique requirements

Apprentices are Network Partners’ W-2

employees with full healthcare benefits, paid

time off and holiday pay

networkpartners.com

574.377.7151

info@networkpartners.com

network-packaging-partners

@NetworkPartner5

@NetworkPartner5 M-012-01

REGULATORY AFFAIRS APPRENTICE PROGRAM

Network Partners

PLAN FOR THE UNPLANNED

For many companies, it’s not a matter of “if” additional regulatory resources are needed, it’s a matter of “when” and “how much”. The Apprentice program addresses this fundamental disconnect between the work that needs to get done and the manner in which it happens. This accelerated training program provides high performing, productive medical device regulatory affairs professionals to our clients. Let our team be part of yours and complete the work necessary to provide your products to patients.

• 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

info@networkpartners.com

network-packaging-partners

@NetworkPartner5

@NetworkPartner5

MEET THE APPRENTICE TRAINING TEAM

M-012-01