Regulatory Affairs Specialist Job Listing at Philips North America in Carlsbad, CA
Consumer Goods, Healthcare
Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.
The Philips Hospital Respiratory Care business has three locations in the United States. Our products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers' problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
The primary responsibilities include serving as the regulatory representative on product development teams. Prepares regulatory strategies to facilitate the launch of new products in the US and internationally. Provides regulatory guidance on standards, design controls and Quality Systems compliance issues to product development teams. Responsible for preparing domestic and international regulatory submissions. Works with and responds to inquiries from regulatory agencies. Develops/enhances regulatory policies, procedures and processes. Creates and maintains Technical Files to the European Medical Devices Directive. Reviews product changes against required regulatory approvals. Reviews labeling and promotional materials to ensure consistency with regulatory approvals.
The secondary responsibilities include communicating relevant regulatory requirements, obtaining international approvals for new/modified ventilation products and accessories developed and manufactured by the business, Device Tracking and SAP RA transactions.
Evaluate and summarize all Change Order activity for annual device license renewals. Prepare and submit annual device license renewals to Health Canada. Support the facility in this area as needed.
Market foresight, learning agility and teaming (key competencies)
Requires 3 years' experience in the interpretation and application of US/International medical device regulations
Experience working in FDA or similarly regulated related industry
Requires excellent written and oral communication skills and working knowledge of computers and software including word processing, spreadsheets, and databases.
Work with minimal supervision and be a self-starter.
Able to recognize departmental and organizational needs and initiate actions and, or recommendations for resolution.
Requires solid problem solving and timely decision making as well as strong leadership abilities.
An ability to communicate effectively with supervisors and co-workers.
Must have a drive for results.
Must have knowledge of GMP and Quality Systems Requirements.
Knowledge of the applicable certified quality standards.
Strong understanding of US and International medical device regulations.
Lifting up to 10 lbs
Travel of up to 10 % will be required, including trips outside the United States.
Philips is an equal opportunity employer.
Apply on Company Website
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