Regulatory Affairs Project Leader

Client:               Medical Device Client

Job Title:           Regulatory Affairs Project Leader

Location:           Santa Clara, CA 95054

Duration:          12 Months of Contract, with possibilities of extension.

Type:                 100% Onsite

Pay:                   $55-60 per hr on W2 without benefits

Openings:         3

Please kindly refer to some key words:

• Knowledge of US and/or Canadian, EU regulation relating to product and/or device clearance (FDA)

• Creation and/or maintenance of EU MDR Technical Documentation

• Prepare and submit product for international registration

In addition to the key words, forgot to mention:

• PMA, IDE submission

• 510(k) submission

Registrations - will train to do this : up to 200 pages of documentation formatting and complete technical documents for different Countries and submit to government agencies as well as the US.

• Education: Bachelor's degree required, Master’s degree preferred
• Experience: Minimum of 3 years of Regulatory Affairs experience Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or device submissions.
• Hands-on experience with 510k submission, or PMA/s or US Annual report or CE Technical Documentation preparation. : Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.

Responsibilities:

• 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 material activities.
• Responsible for effective communication of regulatory requirements to project teams and internal customers.