Responsible for overseeing compliance of marketing/promotional materials, monitoring regulatory compliance activities for Diagnostics, and managing and overseeing the Quality Management System for the Waltham R&D facilities.
This person is responsible for the coordination and effectiveness of the Promotional Review Board.
This person is responsible for monitoring the regulatory requirements of the markets for which PerkinElmer Diagnostics markets products, ensuring those requirements are appropriately communicated and managing initiatives/projects related to regulatory compliance.
This person is also responsible for the management and oversight of the QMS as it relates to Waltham R&D activities ensuring that activities comply with defined procedures from Turku and Waltham.
This individual will focus on advertising/promotion and diagnostics compliance activities with global strategic oversight related to compliance initiatives. The person is responsible for the coordination of as well as overall effectiveness of the Waltham R & D Quality Management System.
- Oversee and manage the Promotional Review Board (PRB) process for reviewing marketing and promotional items to ensure compliance.
- Assess the need for, and onboard, new acquisitions into the PRB process.
- Management and maintenance of electronic review and approval process and repository of regulatory files
- Represent Regulatory Compliance on boards/committees/project teams
- Monitor external regulatory environment for new or changed regulations that impact medical devices manufactured by PerkinElmer.
- Communicate changes in regulations or new regulations and assist or drive inititatives to ensure compliance.
Regulatory Project Management
- Develop and establish the UDI program within PerkinElmer and work with sites to implement according to defined schedule.
- Work with sites to aid in implementation and understanding of the UDI initiative.
- Manage and oversee the Intended Use Analysis process for PerkinElmer.
Diagnostics Business Management Review
- Manage logistics of the Dx QMR and assemble presentation for reporting metric information to top management.
Quality Management System - Waltham
- Partner with Diagnostics Senior Management to
- Define the quality management system components necessary to successfully support Dx.
- Deploy the QMS components/define the resources required for implementation
- Create a training program for QMS/ administer to be effective
- Maintain the QMS
- As needed apply continuous improvement principles to optimize
- Monitor performance and progress against documented objectives
- Support efforts in design of new products and services
- Other duties as deemed necessary and assigned by manager
- Write Regulatory SOPs and corporate policies as necessary
- May interact with state and local regulatory agencies on general/administrative activities
- Facilitate obtaining expert opinion/positions on regulatory projects or initiatives
- Other responsibilities as assigned by the Director of Quality and Compliance
- This position reports to the Director, Quality and Compliance for Diagnostics.
Job Requirements :
Education Bachelor degree ideally in Science or related field, advanced degree a plus Other Training Certifications through ASQ or RAPS and formal training to regulatory standards a plus. Experience 5 - 10 years of quality assurance experience in the medical device or pharmaceutical industry Skills
- Demonstrated ability to lead and influence others.
- Experienced in reviewing materials for compliance to regulations and market approvals/clearances.
- Ability to develop and maintain strong relationships in furtherance of quality goals and objectives.
- Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion; must be able to manage and lead without direct authority.
- Excellent judgment skills in order to provide strong guidance and counsel to staff.
- Extensive knowledge of medical device regulations.
- Time management skills for oneself and of others on a team, ability to drive projects to scheduled completion.
- Superior interpersonal, verbal and written communication skills.
- Exceptional organizational, negotiation, and problem solving skills.
- Must be able to manage and lead without direct authority.
- Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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