Regulatory Affairs Specialist
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 location
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.
Promote teamwork and collaboration within the regulatory function and with other functional areas.
Interact with Marketing, Engineering, Clinical Affairs, Operations and Quality Assurance to develop new products according to the company’s New Product Development process.
Performs duties in compliance with relevant domestic and international regulations.
Provide input to budget, planning, and evaluation processes.
Collaborates with in-country personnel to identify global regulatory requirements for international product registrations. Communicate requirements to International Operations and Sales/Marketing organizations.
Collaborate with project development teams to ensure deliverables for international registrations meet regulatory requirements.
Submit new/amended product dossiers for international registrations.
Work with project development teams to create technical file documentation to support and maintain compliance with the EU Medical Devices Directive.
Review and approve labeling to ensure compliance with relevant international regulations.
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.
Support the preparation and submission of product applications and license amendments to Health Canada.
Post-market product sustaining support.
Provides documentation in support of new product bids for domestic and international sales. Monitor the regulatory environment.
Stay abreast of changes in regulations throughout all major international geographies.
Market foresight, learning agility and teaming (key competencies)
Ability to deal with multiple tasks and complex projects
An action/problem solving orientation
Interpersonal and influencing skills (across all organizational levels), effective communication through interface with Respironics EU Authorized Representative.
Effective communication through interface with Notified Body regarding issues related to CE marking and Certificates.
Effective communication through interface with FDA regarding issues of Device Listings/Establishment Registrations.
Effective communication through interface with Health Canada on product licenses
Define with their manager goals for personal and professional development
Take accountability to execute their personal development plan to grow within their current role and to prepare for future roles
BS in science, engineering, or related discipline or equivalent.
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.
Excellent written and oral communication skills.
Ability to effectively interface with all functional areas.
Ability to make decisions where authority is given.
Ability to work independently in a fast-paced environment.
Excellent organizational skills.
Customer Focus, Action-Oriented, Building Team Spirit, Self-Development, Creativity & Innovation, Problem Solving, Ethics & Values.
Managing Through Systems, Organizing, Managing and Measuring Work, Negotiating, Functional/Technical Skills, Comfort Around Higher Management, Business Acumen.
This position functions in an environment that requires the ability to interface with standard office equipment such as computers, printers, copiers, fax, telephones, etc. Position will spend periods of time sitting, standing, walking, etc., as part of the normal conduct of daily business affairs.
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.
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