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Title Location Type Rate Apply
Sr. Director Regulatory Affairs Boulder, CO Perm/Full Negotiable

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Sr. Director Regulatory Affairs
SUMMARY OF POSITION:
Position will oversee pre-market submission and registration for new products. Reviews, evaluates, and compiles files and reports for submissions. Ensures clinical trial protocols are properly designed to support regulatory objectives.
Supports rapid and timely global approval on new and current products. Interacts with global regulatory personnel in order to expedite approval of pending registrations. Ensures compliance with FDA and global regulations and interpretations.

ESSENTIAL FUNCTIONS:
1.Establish Regulatory Affairs policies, procedures and controls to ensure that products meet applicable standards and specifications.
2.Responsible for directing efforts associated with Regulatory Compliance as it relates to product quality.
3.Direct the efforts of the Regulatory Affairs department regarding goals, objectives, leadership strategies, and employee development. Interact with all departments and other Company Healthcare divisions.
4.Develop project/program requirements; establish, coordinate and control schedules and report on status.
5.Coordinate, review and approve department budgets.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1.Apply expertise to all direct departments and provide proper leadership.
2.Establish and review RA priorities as they relate to department and company goals and objectives.
3.Approve personnel hiring.
4.Establish, review and approve bonus objectives for direct staff.
5.Approve strategies for global Regulatory filings and compliance.
6.Develop strategies as they relate to changes to approved devices.

Requirements MINIMUM REQUIREMENTS:

Education required/ preferred: College Degree
Experience:10-15 years, 5-10 management in Medical Device or Pharmaceuticals.
Preferred Skills/Qualifications:
Management abilities, w/ Technical, QA/RA experience. Specific experience with FDA regulations and audits essential.
Skills/Competencies: Good written and oral communication background.
Other Skills: Good interpersonal skills. Familiarity with design control process. Demonstrate good decision making skills.

WORKING CONDITIONS:
Office, Travel Worldwide, Customers, Vendors, Plants, Subsidiaries, Government Agencies.