Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
The Senior Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including participation on new product development teams and continued RA support through the lifecycle of the product.The Senior RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The Senior RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. The Senior RA Specialist has developed expertise in international regulatory requirements as they apply to medical devices.
Job Description
As part of our Regulatory Affairs department, you will be responsible for the global regulatory strategy and all related activities for one or more product lines, including participation on new product development teams and continued RA support through the lifecycle of the product.
The Senior RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The Senior RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. The Senior RA Specialist has developed expertise in international regulatory requirements as they apply to medical devices. You are also representing the company towards the authorities. The role reports directly to the Head of RA.
Main tasks:
- Establishing and maintaining registration documentation according to current regulations (Swiss Medical Devices Ordinance MEDDEV). Main contact person for all questions relating to Swiss law.
- Support for international registrations as well as representation at audits and inspections by the relevant authorities
- Review of product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communication of changes to global regions and supports preparation of global notifications as needed
- Maintanance of regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s) as needed.
- Implementation of appropriate measures in the event of non-compliance with regulations.
Requirements:
- Bachelor’s degree or advanced degree in technical area such as biology, engineering or medical-related field and minimum of three years of experience, or equivalent combination of related education and experience
- Preferred minimum of two-to-four years of experience in the medical device industry with at least one year in a regulatory role
- Strong communication skills
- Fluent English written and spoken
- German language skills are desirable
- Flexibility
- Team spirit
Required Skills
Optional Skills
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Primary Work Location
CHE Wangs - StraubstrasseAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.