Job Description :
Company Overview:
Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.
Our client, is the world''s largest independent multinational biopharmaceutical company, seeks an accomplished Senior Associate Software Labeling Lead.
Description:
Collaborating with subject matter experts in creating labeling for software regulated as a medical device.
Managing the process by which Client develops, reviews, approves, and maintains core, clinical, and commercial (regional) software labeling.
Developing and implementing processes for both new and existing software products regulated as a medical device.
Creating, developing, and maintaining the process to construct, review, approve, and maintain software labeling.
Obtaining cross-functional review/approval of software labeling.
Ensuring the dissemination of approved software labeling and supporting documentation.
Ensuring quality of software labeling deliverables (e.g., alignment of labeling text with data, ensuring regulatory requirements are met, providing consistency across associated software labeling
Contributing to the continuous improvements of the end-to-end labeling process.
Contributing to and implementing the global labeling strategy.
Contribute to and participate in ongoing software labeling education and training.
Identify, communicate and participate in review of relevant draft regulations and guidance.
Knowledge and Skills:
Bachelor’s degree, preferably in Regulatory Affairs, Life Sciences, Engineering, or related field.
At least one year of experience in combination product or medical device software industry, to include knowledge of labeling regulations, medical app development, design verification/validation requirements, and drug and/or device development.
Knowledge of regulatory requirements and standards that govern software labeling for medical devices.
Effective regulatory and cross-functional meeting facilitation, collaboration and negotiation skills.
2+ years of experience leading teams within a global, highly collaborative environment.
US and International Regulatory Affairs experience preferred, e.g. design controls, CE marking, application of international device standards (ISO 14971, ISO 13485, ISO 14155, ISO 11608
Attention to detail, Recognize and escalate issues, Time management, Problem solving and conflict management, Interpersonal skills.
Effective regulatory and cross-functional meeting facilitation, collaboration and negotiation skills, Change implementation.
Management (accomplishing goals through best use of resources; work through efficiency), Integrity, Operation in global, fast-paced, complex, and dynamic environment.
Oral and written communication, to include presentations, Planning and organization, Prioritization, Support for team members, Managing and measuring work.
Microsoft suite – Outlook, Word, Excel, PowerPoint.
I''d love to talk to you if you think this position is right up your alley.
If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven. We also offer group health Insurance (employee paid on a pre-tax basis
NOTE: “Candidates that are offered a position are required to pass pre-employment drug and background screening”