Regulatory Affairs Specialist (IDBU)
Medtronic - Northridge, CA

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Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description

The Regulatory Affairs Specialist will represent Regulatory Affairs on new product and therapy development teams, product continuation teams, and other business initiatives. The Regulatory Affairs Specialist will provide strategic guidance regarding domestic regulatory requirements and have responsibility for obtaining and maintaining worldwide product and therapy approvals.
Position Responsibilities

Assists with preparation of US regulatory submissions including IDE, PMA, and 510(k) submissions, amendments, and supplements

Negotiates with regulatory agency, staff, and lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies

Collaborates with RA partners to support filings

Provides regulatory affairs tactical support for all aspects of product development and manufacturing, clinical studies including pre-market, post-market and physician-initiated studies

Supports regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed

Maintains proficiency in regulatory requirements; establish and maintain good relationships with agency personnel

Establishes and builds upon broad personal network across functions, throughout Medtronic, with regulators and external industry bodies

Demonstrates proficiency in regulatory knowledge in pre- and post-market submissions, products, and geography regulations

Plays and active role in effectively planning and driving successful completion of complex cross-functional projects

Maintains strong understanding of product lines/disease states, customers, product distribution release processes and geography launch/maintenance requirements

Works with Regulatory Affairs staff, engineers, and technical experts to resolve questions and issues

Effectively communicates project plans, status and resource requirements to both core teams and senior management

Partners with other Regulatory Affairs Specialists and others in the organization

Other duties as assigned
Basic Qualifications

Education & Experience Required:
Bachelor’s degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field and 3 years’ of related experience in regulatory

OR

Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field and
1 years of related experience in regulatory

Other Requirements:
Organized, efficient, process-oriented

Effective interpersonal/communication skills; demonstrated advanced writing/technical writing skills

Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

Self-motivated and proactive team member

Strong work ethic

Works well under pressure in a dynamic timeline-driven environment
Desired/Preferred Qualifications

Education & Experience Preferred:
More than 4 years’ of related experience Bachelor’s degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field

OR

More than 2 years’ of related experience with Master’s degree or Doctorate in Regulatory Affairs, Engineering, Quality or related Technical field

Other preferred qualifications:
Experience in medical device

Working knowledge of medical device regulations, including submissions

Have detailed knowledge of domestic and international medical device regulatory requirements.
Ability to effectively manage multiple projects and priorities.
Results-oriented and decisive.
Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards.
Flexible with priorities and responsibilities.
Regulatory Affairs Certification (RAC) preferred.
Physical Job Requirements

Able to sit/stand for 8 hours per day
Able to travel domestic/international up to 20% of the time

Medtronic - 2 years ago - save job
About this company
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Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...