Regulatory Affairs Project Leader

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact our Talent Specialist

Meghna at (224) 369-4230

Title: Regulatory Affairs Project Leader

Location:Santa Clara, CA

Duration: 1 Year

Description

Exempt/Non-Exempt: Non-exempt

Education: Bachelor's degree in engineering or science

Experience: Minimum of 3 years of experience of regulatory affairs

Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)

Duties

• Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
• Communicates issues to management through project management tracking and issue briefings.
• Position is highly visible to internal and external stakeholders.
• High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
• Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.
• Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
• Ability to manage and track broad and strategic projects.
• Ability to communicate effectively in writing crisp briefings and issue analysis.
• Demonstrated ability to work effectively in a team environment.
• Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
• Responsible for effective communication of regulatory requirements to project teams and internal customers.
  
  

Must Have

• RA submission experience and EU & MU submissions experience
• Good writing and communication skills - Word, Excel
• Day to day registrations - will train to do this
• Up to 200 pages of documentation formatting
• Complete technical documents for different Countries and submit to government agencies as well as the US.
  
  

About Us

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.