Megan Clark

• Phone: +353 87 123 4567
• Email: megan.clark@email.com
• Location: Dublin, Ireland
• LinkedIn: meganclarkregulatory

Summary

Navigated complex EU medical device regulations, achieving CE Mark approval for 15+ Class IIb and III devices over 7 years. Spearheaded cross-functional teams to ensure compliance with MDR (EU) 2017/745 and IVDR (EU) 2017/746, significantly reducing time-to-market.

Expert in regulatory submissions, post-market surveillance, and quality management systems, consistently maintaining audit readiness and ensuring product lifecycle compliance in the pharmaceutical and medical device sectors.

Experience

Senior Regulatory Affairs Specialist, MedTech Ireland Ltd. -- Dublin, Ireland

Mar 2019 – present

• Led regulatory strategy and submissions for a portfolio of high-risk medical devices, securing CE Mark approval for 8 Class III devices under MDR.

• Managed post-market surveillance activities, including vigilance reporting and PMSP updates, reducing incident reporting time by 25%.

• Authored and reviewed clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) in accordance with MEDDEV 2.7/1 Rev 4.

• Provided expert guidance on regulatory requirements for product development teams, ensuring design control and risk management compliance.

Regulatory Affairs Specialist, Pharmaco Ireland -- Cork, Ireland

Sept 2016 – Feb 2019

• Prepared and submitted CTA/IND applications and variations for Phase I-III clinical trials, contributing to the successful initiation of 5 new studies.

• Maintained compliance with GxP regulations (GCP, GMP, GLP) and Irish Medicines Board (HPRA) guidelines for pharmaceutical products.

• Assisted in the preparation of marketing authorization applications (MAA) for generic drugs, resulting in 3 successful approvals.

• Coordinated responses to regulatory agency inquiries and inspections, ensuring timely and accurate information submission.

Education

University College Dublin, Master of Science in MSc in Regulatory Affairs -- Dublin, Ireland

Sept 2015 – Sept 2016

National University of Ireland Galway, Bachelor of Science in BSc in Biomedical Science -- Galway, Ireland

Sept 2011 – June 2015

Skills

Regulatory Expertise: MDR (EU) 2017/745, IVDR (EU) 2017/746, FDA Regulations (21 CFR), ISO 13485, GxP (GCP, GMP, GLP), CE Marking, HPRA Guidelines, MHRA Regulations, TGA Regulations

Regulatory Submissions: CE Mark Applications, 510(k) Submissions, PMA Applications, CTA/IND Applications, MAA, Technical Documentation, Design Dossiers, Clinical Evaluation Reports (CERs), Post-Market Surveillance Plans (PMSPs)

Quality Systems: Quality Management Systems (QMS), Internal Audits, External Audits, CAPA Management, Risk Management (ISO 14971), Supplier Qualification

Software & Tools: Microsoft Office Suite, SharePoint, Document Management Systems (e.g., Veeva Vault), Regulatory Information Management Systems (RIMS)

Languages: English (Native)