Global Regulatory Affairs Manager
Global Regulatory Affairs Manager
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Job Description
Why join us
Were on a mission to empower people with disabilities to do what they once did or never thought possible. As the world-leader in assistive communication solutions we empower our customers to express themselves connect with the world and live richer lives.
At Tobii Dynavox you can grow your career within a dynamic global company that has a clear impactful purpose - with the flexibility to also do what truly matters to you outside of work. Whats more youll be part of a work culture where collaboration is the norm and individuality is welcomed.
As a member of our team youll have the power to make it happen. Youll solve challenges deliver solutions and develop new efficient processes that make a direct impact on our customers lives.
About the Role:
As a Global Regulatory Affairs Manager you will join our Quality and Regulatory this pivotal role youll develop and execute global regulatory strategies to ensure our medical devices comply with requirements in key markets including the EU US and other strategic regions.
You will also act as one of our Persons Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15 with a primary focus on technical documentation post-market surveillance (PMS) and vigilance.
Please note: This hybrid role includes 2-4 days from our office in Stockholm city with flexible working hours. It can include occasional travel (1-2 times per year) to our other locations across the world. Business trips are communicated in advance.
In this role you will:
Global Regulatory Strategy and Operations
Develop regulatory strategies for product registrations and lifecycle management in compliance with EU MDR FDA QSR MHRA SFDA and other global requirements.
Coordinate declarations of conformity and labelling compliance and ensure technical documentation and EU declaration of conformity are up to date.
Oversee adverse events and field safety corrective action (FSCA) reporting in the EU and other jurisdictions.
Monitor global regulatory changes and communicate their business impact.
Post-Market & Regulatory Compliance Lead (PRRC under EU MDR Article 15)
Act as a primary contact for regulatory authorities notified bodies and authorized representatives.
Align PMS planning and execution with EU MDR requirements.
Ensure post-market surveillance and reporting obligations (vigilance and serious incidents) are fulfilled.
Coordinate regulatory submissions and maintain regulatory documentation databases and tracking systems for audit readiness.
Cross-functional Collaboration and Support
Collaborate closely with QA Clinical and Product teams for regulatory alignment during product development and changes.
Contribute to QMS integration and multi-site continuous improvement initiatives.
Participate in Notified Body audits regulatory inspections and customer inquiries.
What Were Looking For:
The ideal candidate would have the following qualifications and experience:
Bachelors degree or equivalent education in life sciences engineering or another relevant scientific field.
Approximately 10 years of regulatory affairs experience ideally in a multi-site and global environment.
Extensive experience with regulatory frameworks such as EU MDR FDA 21 CFR 820 and ISO 13485.
Knowledge of GSPR EUDAMED and UDI requirements preferably with a great understanding of medical device regulatory frameworks and familiarity with SaMD (Software as a Medical Device).
Previous experience in managing technical documentation and PMS systems and interacting with regulatory agencies and notified bodies.
Knowledge of electrical and electronic devices is a plus.
Strategic and analytical thinking with integrity and compliance mindset.
Strong communication coaching and cross-functional collaboration skills.
Please note: Experience in medical devices is required.
Apply today!
We believe in empowering individuals - including our own employees - to reach their full potential. So if you want to change lives while growing your own career wed love to hear from you.
Required Experience:
Exec
Employment Type
Full-Time
