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Senior Regulatory Affairs Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2350503 |
| Location: Santa Rosa, California |
Date Posted: 7/8/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6141822 |
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Job Description:
Lead and manage activities that create and improve regulatory business systems, as appropriate, in order to facilitate accurate, timely, and sustainable regulatory compliance, submissions, and reporting activities. * Act as the primary systems-level regulatory interface with the Clinical Research and Biostatistics/Data Management; as needed on a project level. * Direct staff on process improvement initiatives and contribute to activities relating to regulatory initiatives by Medtronic in matters directly and/or indirectly affecting the business. * Provide work direction, training and project advice to direct reports and mentoring other members of the regulatory department. * Provide management and leadership to the Regulatory Affairs Group in such areas as people management, objectives, projects and responsibilities. * Interact with Corporate Regulatory/Regulatory Affairs Specialists and other groups on company-wide initiatives as well as other internal and external executive level management requiring negotiation of challenging regulatory and clinical issues. * Conduct annual performance reviews. Set objectives and devise professional development plan of staff. * Provide continuing regulatory and clinical guidance and dissemination of regulatory policy and current information to the staff. * Represent Medtronic before global regulatory agencies on major policy matters and decisions regarding Medtronic Vascular\'s products and therapies. * Manage and/or provide responses to FDA and other regulatory agencies regarding product information or issues. * Ensure support on new product development, post market surveillance, and regulatory reporting requirements * Provide regulatory input and direction for the design and implementation of all product and market development studies for approved indications to ensure compliance and to meet overall business needs (e.g. risk management, reimbursement etc.).
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.biotechcrossing.com
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