Are you ready to unlock your potential?
At Straumann Group we're on an exciting journey of growth, innovation, and impact - driven by our mission to improve oral health and transform millions of lives worldwide. United by purpose, we bring our best selves to work every day, embracing a high-performance, player-learner culture that inspires collaboration, curiosity, and ambition. Here, you'll have the opportunity to take charge of your own career, harnessing your skills, passion, and enthusiasm for learning to continually grow and progress. Together, we're not just shaping brighter smiles, we're unlocking the potential of people everywhere, including our own.
Introduction
As Regulatory Affairs & Compliance Manager, you will play a central role in shaping and executing regulatory strategies for our medical device portfolio. You will ensure that our products meet applicable regulatory requirements across key markets, supporting timely product registrations and maintaining ongoing compliance. Working cross-functionally with Product Development, Quality, and international Regulatory Affairs teams, you will contribute to bringing innovative medical technologies to market while safeguarding patient safety and regulatory excellence.
Your Role
* Define and execute regulatory strategies for medical device registrations.
* Represent Regulatory Affairs, Design Control, and Quality requirements in product development projects.
* Lead and contribute to the creation and maintenance of Technical Documentation in accordance with MDR 2017/745.
* Prepare and compile regulatory submissions for international markets, including the United States and Canada.
* Create and maintain Declarations of Conformity.
* Collaborate closely with Straumann's global Regulatory Affairs organization.
* Interface with health authorities, notified bodies, and other regulatory stakeholders.
* Assess device classification and regulatory pathways in line with applicable regulations.
* Provide guidance to internal departments on regulatory requirements and interpretation of applicable laws and standards.
* Identify regulatory risks in submissions and proactively plan mitigation strategies.
Success in this role means ensuring compliant, efficient product registrations while supporting innovation through clear regulatory guidance and collaboration.
Your Profile
Must-haves:
* Bachelor's or Master's degree in a technical or scientific field.
* Professional experience in Regulatory Affairs and/or Quality Management within the medical device industry (Class IIb experience preferred).
* Solid knowledge of relevant medical device standards and regulations (e.g., MDR 2017/745, ISO 13485, ISO 14971).
* Experience preparing or supporting regulatory submissions.
* Excellent written and spoken English and Spanish.
Nice-to-haves:
* Experience participating in or supporting quality audits.
* Familiarity with international regulatory frameworks beyond the EU.
* Experience with document management systems and regulatory software tools.
* Additional language skills.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
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