This position implements C.R. Bard domestic and international regulatory affairs (RA) procedures. This position may also act as a liaison to Corporate Law Department, providing requested information.
The ideal candidate must be able to work in a team oriented, fast paced environment. Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Summary of Position with General Responsibilities:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
1. On assignment, implements or oversees all aspects of an Investigational Device Exemption (IDE) clinical study according to the C.R. Bard Clinical Affairs Standard Operating Procedures and FDA regulations, including on-site monitoring of investigational sites, maintaining records, and submitting timely reports.
2. Coordinates the preparation of IDE protocols between Bard Medical Affairs and the new product project team.
3. Serves as RA representative on new product development teams.
4. Develops and administers new product field trials as required.
5. Coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new BAS products.
6. Performs RA reviews for BAS labeling change requests.
7. Performs special projects such as administering recalls.
8. On assignment, provide documents to Bard Corporate Law Department to satisfy the discovery documentation production requests, gather the required information and data for drafting responses to interrogatories, and interact with Corporate Law Department members and outside counsel. Also, assist in production of defense kits to brief and educate defense counsel in conjunction with corporate counsel.
9. On assignment, serve as the BAS international information contact person, coordinate the preparation of International Dossiers with the Product Teams and disseminate the dossiers to the appropriate parties. Update dossier information and completion schedules as required.
10. Travel as required to professional meetings or product liability trials.
KNOWLEDGE AND SKILLS:
1. Good understanding of US, CE and international medical device regulations.
2. High scientific, analytical evaluation skills.
3. Good written and oral communication skills.
4. Ability to work well with New Product Development teams.
This position requires a Bachelors Degree in Law, Life or Engineering Science plus two to three years regulatory affairs experience or equivalency. This position requires regulatory experience with submissions to FDA. This position also requires demonstrated communication and human relation skills.
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.