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C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.
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| Overview: |
Regulatory Affairs Associate
Davol Inc.
Warwick, RI
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| Summary of Position with General Responsibilities: |
The position of Regulatory Affairs Associate will report to the Senior Manager/Director Regulatory & Clinical Affairs. This individual will be responsible for providing technical and administrative direction to ensure the timely introduction of new products subject to medical products regulations. This position will also provide regulatory support to marketed products.
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| Essential Job Functions: |
Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)'s, IDE's, PMA's) Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed. - Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
- Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers).
- Assist Product Development and Quality Assurance in planning animal studies and bench testing that will ultimately be used in regulatory submissions.
- Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
- Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
- Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
- Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
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| Basic Qualifications: |
* B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred.
* Knowledge and experience 2-3 years with regulatory requirements for medical devices including submission of IDE’s, PMA’s and 510(k)’s, and CE mark technical files.
* Knowledge of US and EU medical product regulations.
* Strong analytical and technical writing skills.
* Professional communication demeanor
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| Additional Desirable Qualifications Skills and Knowledge: |
Good oral and written communications skills and ability to work on cross-functional teams. Working knowledge of statistics and electronic documentation and information systems. Ability and desire to travel as needed.
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C. R. Bard, Inc. and its Subsidiaries are an equal opportunity/affirmative action employer. We consider applicants without regard to race, color, religion, gender, national origin, age, disability, veteran status, sexual orientation, or any other characteristic protected by applicable law.
