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Donielle Johnson

Regulatory Strategy Consultant
JRC, Netherlands

Donielle Johnson is the former Vice President Global Regulatory Affairs, Policy and Intelligence at Bausch + Lomb.
With 20 years of medical device experience, she has led global organizations that support strategic priorities ensuring access to innovative technology and compliant maintenance of business. Additionally, Donielle partner's closely with stakeholders across medical device businesses (e.g. cardiac, orthopedics, imaging, wound closure, ophthalmology, etc.) and has been a representative in various internal and external forums with regulatory bodies, health authorities and trade associations.

In her previous role she created a Global Regulatory Affairs Policy Council. The main aim of the council was to create strategies for responding to DRAFT guidance documents, supporting local trade associations with talking points for meetings with ministries of health, creating impact assessments on new or changing regulations, and making regulatory more relatable to business leaders.

Donielle has global medical device strategy experience and has negotiated innovative product approvals in developed and emerging markets. Additionally, she has practical expertise writing submissions to the FDA (510k, PMA, CMC), obtaining the European Union CE Mark (under MDD and MDR), Health Canada device applications, and Japanese shonin. Donielle is a champion of quality and has experience creating an ISO 13485 and 21CFR820 compliant QMS and representing regulatory affairs during post market surveillance issues.

Donielle is a leader who likes to inspire and empower the team to think outside the box to solve regulatory issues while keeping the patient at the center of everything that we do. She is a mentor who enjoys sharing her knowledge with young scientists and engineers who are seeking careers within medical devices.

A native New Orleanian who is a global citizen that currently resides in Amsterdam. She loves to travel, cook, go wine tasting, do hot yoga, read, and spend time with her family and friends.





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