Sr Regulatory Affairs Spec
Location: Northridge California
Description: Medtronic is currently interviewing Sr Regulatory Affairs Spec right now, this vacancy will be placed in California. More complete informations about this vacancy opportunity please give attention to these descriptions. Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description
The Senior Regulatory affairs Specialist is responsible for developing reg! ulatory strategy, preparing U.S. and international submissions and obtaining approval to introduce Medtronic MiniMed products and therapies to markets worldwide.
Position Responsibilities
Team with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Prepare FDA submissions for new products and product changes as required to ensure timely approvals and market release. Review only significant submission decisions/content issues with manager; negotiate submission issues with agency personnel.
Provide support for currently-marketed products. This includes reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.
Manag! e product dossiers and technical files for Medtronic MiniMed p! roducts.
Participate in team meetings and provide support on regulatory issues and questions.
Maintain proficiency in worldwide regulatory requirements; monitor changes to regulatory requirements and communicating this information to departments within the business unit that may be affected by these changes; establish and maintain good relationships with agency personnel.
Review and Revise SOPs, and other company and departmental procedures to ensure quality system compliance.
May mentor or supervise other RAS, as directed by manager..
Performs other duties as assigned.
Basic Qualifications
EDUCATION AND WORK EXPERIENCE REQUIRED:
Bachelor’s Degree and 4 years work experience in regulatory affairs, clinical or quality or
Master’s Degree and 2 years of work experience in regulatory affairs, clinical or quality
Experience in a highly regulated industry (medical device, pharmaceutical, biotechnolog! y)
SPECIALIZED KNOWLEDGE REQUIRED (Needs to be objective, relevant, and non-comparative)
At least 2 years of experience in preparing regulatory submissions
Experience handling multiple projects and priorities
Good oral and written communication skills
Effective interpersonal skills
Good analytical thinking skills
Proficient computer skills
Desired/Preferred Qualifications
Have detailed knowledge of FDA and European regulatory requirements
4 or more years of experience in preparing regulatory submissions (domestic and international) for Class II AND Class III (FDA classification scheme) medical devices or pharmaceuticals
Experience with submitting the following: Premarket Approval (PMA) supplements, 30-day notice or 510K notifications
6 more years of experience in regulatory affairs, clinical or quality
Regulatory Affairs Certification (RAC) preferred
Advanced degree in scientific di! scipline or equivalent
Degree in the areas of engineering or p! hysical/biological sciences
Effective communication with external agencies (FDA or notified body)
Strong work ethic
Self-motivated and proactive team member
Ability to comprehend principles of engineering, physiology and medical device use
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
While performing the duties of this job, the employee is regularly required to talk or hear, frequently required to sit and! reach with hands and arms, and regularly required to stand; walk and use hands to finger, handle, or feel.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Medtronic.
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This vacancy starts available on: Thu, 18 Jul 2013 13:26:15 GMT