- Be energized by joining a world-class company and regulatory team
- Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA
- Provide ongoing support to project teams for regulatory issues and questions. Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance
- Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings
- Develop solutions to a variety of technical problems. Assist in the maintenance and improvement of regulatory SOPs
- Interact and negotiate with regulatory agencies on defined matters as needed
- Regulatory affairs experience in the medical device industry with a track record of successful submissions
- Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance
- Ability to effectively manage multiple projects and priorities
- Strong communication and regulatory writing skills
- Ability to drive to completion in adherence to aggressive project schedules
Senior Regulatory Affairs Specialist - Digby, NS, Canada - Johnson & Johnson
Description
Job Description - Senior Regulatory Affairs Specialist W)Senior Regulatory Affairs Specialist W
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist . Remote work options may be considered on a case-by-case basis and if approved by the Company
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
Through your engagement in this role, you will help shape the life-saving field of heart recovery.Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices
Must be able to effectively work remotely
The Company maintains highly competitive, performance-based compensation programs. .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance
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