- Ensures compliance with applicable national and international regulations and standards during all phases of the product life cycle.
- Directs the development and implementation of systems for the preparation of quality submissions, which meet regulatory requirements to ensure timely device approval and maximize market opportunities.
- Assists clients in the development of documentation designed for FDA, Competent Authorities, Notified Bodies, and other related regulatory authorities.
- Assists in regulatory inspections, field corrective actions, post market surveillance, patient registration, device tracking, complaint reporting and MDR and vigilance reporting activities.
- Supports the development and implementation of product development, manufacturing and strategic operating plans.
- Establishes project timelines/schedules.
- Interacts with clients and potential clients, as appropriate.
- Represents and assists in the marketing of Covance capabilities and services throughout the medical device product industry and related affiliations.
Other duties as assigned.
- Bachelor’s degree plus four or more year’s applicable experience with medical devices or regulatory agency. Advanced technical degree with at least 2 years’ experience.
- Project management experience preferred.
- Ability to comprehend the engineering principles, clinical, and physiological aspects of medical devices.
- Effective oral and written communication skills.
- Effective interpersonal skills.
- Strong organizational skills and detail-orientation.
- Demonstrated abilities to communicate cross-functionally throughout organizations.
- Familiarity with basic computer applications, e.g., Word, PowerPoint.
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