This position implements C.R. Bard domestic and international regulatory affairs (RA) procedures.
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 the preparation of Investigational Device Exemption (IDE) protocols between BAS Medical Affairs office and product teams, writes an IDE and aids with its implementation. May work with contract research organizations to develop and implement clinical trial protocols.
2. Serves as RA representative on product teams as assigned and signs test protocols and reports as required.
3. Develops and administers new product field trials as required.
4. Coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new BAS products.
5. Review and approve documentation Change Requests and labeling artwork changes per BAS and corporate SOPs.
6. Performs GMP/ISO 9000 audits as requested by Department Head.
7. Performs special projects, such as administering recalls, as required by Department Head.
8. Maintain FDA medical device listing/registration information as requested for BAS and Reynosa.
9. As requested, serves as alternate BAS facility FDA inspection coordinator.
10. Prepares and submits PMA annual report and approve PMA related Change Requests.
11. Serves as the BAS international information contact person, coordinates the preparation of BAS international dossiers with the assigned product teams and updates them as required.
12. Travels as required, perhaps on short notice, as assigned.
13. Develop and maintain MDR and vigilance reporting paradigm.
KNOWLEDGE AND SKILLS:
1. Excellent understanding of US, CE and international regulatory requirements.
2. Solid scientific analytical evaluation skills.
3. Ability to work independently with little supervision.
4. Ability to handle stressful situations (i.e. FDA or KEMA audits) in a professional manner.
5. Excellent writing ability is a must.
This position requires a Bachelor's Degree in a Life or an Engineering Science plus five or more years US, CE and international regulatory affairs experience. Exposure to GMP/ISO 9000 training is mandatory. The incumbent must have demonstrated communication and human relation skills. Experience with MDR and vigilance reporting determination, or equivalent, is required. Experience representing Regulatory Affairs on a cross functional team is required.
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...