Michaela is head of our Product Regulatory team. In addition, Michaela is our Life Sciences sector lead. She advises clients across a number of industries on regulatory compliance, product safety and product liability.
Michaela advises life sciences, technology, cosmetic and consumer product clients on the regulatory framework applicable to their products and services throughout their life cycle. This includes advising clients on all issues they encounter on the EU market from R&D, marketing authorisations & CE marking, packaging, market access, product launch and marketing, through to safety issues, product recall and defending product liability claims. She is known in particular for her experience in working as EU counsel with a number of global technology and life sciences companies and advising them on their digital health strategies, with a particular focus on software medical devices and wearables.
Michaela also frequently advises clients on regulatory investigations by enforcement authorities. She has also overseen the implementation and coordination of high volume product withdrawals and product recalls, including rectification strategies, in multiple jurisdictions.
Michaela has also acted on behalf of clients in significant commercial disputes including judicial reviews and product liability class actions, particularly in the medical device industry. Her work is recognised internationally by clients, particularly her proactive and strategic approach. Michaela was named as the sole winner of the Lexology Client Choice Award for Life Sciences in Ireland in 2022 & 2023.