Mary Mellows is a seasoned Principal Regulatory Specialist at Hologic, Inc., bringing over 20 years of extensive experience in medical device regulatory affairs to the forefront of her role. Her expertise encompasses a wide array of regulatory responsibilities, particularly focusing on FDA Class I and...
Mary Mellows is a seasoned Principal Regulatory Specialist at Hologic, Inc., bringing over 20 years of extensive experience in medical device regulatory affairs to the forefront of her role. Her expertise encompasses a wide array of regulatory responsibilities, particularly focusing on FDA Class I and II devices, including 510(k) clearances, as well as European Union Class I, IIa, IIb, and III breast biopsy marker product lines. Mary is adept at navigating the complexities of regulatory submissions, having successfully created, submitted, and maintained numerous 510(k) submissions and MDR-compliant Technical Documents. Her analytical skills enable her to develop robust regulatory strategies and conduct thorough change control assessments, ensuring compliance with stringent industry standards.
In her current position, Mary plays a pivotal role in cross-functional project teams, where her strong leadership and collaborative abilities shine. She is known for her detail-oriented approach and her capacity to manage multiple projects simultaneously while maintaining a positive and professional demeanor. Her proficiency in Lean Six Sigma methodologies, complemented by her training in CAPA and Design Control, allows her to streamline processes and enhance operational efficiency.
Mary's commitment to excellence is reflected in her strong work ethic and judgment, making her an invaluable asset to Hologic. Her ability to communicate clearly and effectively, coupled with her organizational skills, ensures that all stakeholders are informed and aligned throughout the regulatory process. As she continues to contribute to innovative projects within the medical device sector, Mary remains dedicated to advancing regulatory compliance and fostering a culture of quality and safety in healthcare.
