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Global Regulatory Lead
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Raleigh, United States UCB Full time Make your mark for patientsWe are looking for a Global Regulatory Lead to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta or Raleigh (US) offices. About the roleThe Global Regulatory Affairs Leader provides regulatory leadership to assigned Mission and/or asset. ...
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6 days ago
Raleigh, North Carolina, United States Merz North America Full timeSenior Regulatory Compliance Specialist - Medical DevicesJob Category: Research and DevelopmentPosition Overview:The Senior Regulatory Compliance Specialist for Medical Devices is responsible for overseeing regulatory initiatives associated with product development and lifecycle management.Key Responsibilities:1. Collaborate with cross-functional teams to...
Regulatory Affairs Specialist
2 months ago
A global medical device company continuously innovated with new products and technologies that revolutionize treatments for doctors and their patients.
The Regulatory Affairs Specialist will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail.
In this role, you will...
- Perform regulatory assessments for product changes including regulatory reportability decisions
- Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions
- Support regulatory filing like a 510(k) or Pre-submission or a new/amended Health Canada License application for a Class II new product and may include renewal of Licenses
- Support international regulatory filing
- Assist in streamlining or updating regulatory processes
- Assist in regulatory intelligence activities
- Assist in post-market surveillance activities, such as complaint handling and vigilance reporting
- Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance
- Perform other related assignments as required
In this role, you’ll need ...
- Bachelor’s degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
- Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office:
- 1-2 years experience in medical device industry. Experience of medical device, SaMD development, or regulatory affairs is preferred
- Knowledge of US regulation in medical device is required
- In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint
- Motivated and quick to learn new concepts and understand technical writing and medical device regulations
- Proficient written and oral communication skills
- Organized and detail-oriented
- Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace