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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.

We are flexible! This position can be either full time or part time based on need and individual agreement.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

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

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit: https://bd.com/careers

Required Skills

Optional Skills

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Primary Work Location

CHE Wangs - Straubstrasse

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.