Regulatory Affairs Specialist
7 days ago
Regulatory Affairs Project Leader
Location: 4551 Great America Parkway, Santa Clara CA (Onsite)
Rate: $58/hr on w2
Duration: 1+ year of contract
Responsibilities:
- Registrations - will train to do this
- Upto 200 pages of documentation formatting
- Complete technical documents for different Countries and submit to government agencies as well as the US.
- 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.
- 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.
Qualification: Bachelor's degree in engineering or science and a minimum of 3 years of experience of regulatory affairs.
Required Skills:
- Must have RA submission experience. and EU & US submissions experience
- 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
- good writing and communication skills - Word, Excel
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