We are in search of a versatile Regulatory Affairs Project Leader to join our all-star team at DivIHN Integration Inc in Santa Clara, CA.
Growing your career as a Full-Time Regulatory Affairs Project Leader is a terrific opportunity to develop productive skills.
If you are strong in teamwork, creativity and have the right determination for the job, then apply for the position of Regulatory Affairs Project Leader at DivIHN Integration Inc today!
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Divya | 224 369-2969
Rashi | 630-847-1027
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.
Benefits of working as a Regulatory Affairs Project Leader in Santa Clara, CA:
● Career Growth Potential
● Continuous Learning Opportunities
● Attractive packageCompetitive Pay