Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor’s degree in a relevant scientific or technical field, such as Biology, Chemistry, or Pharmacy, and have a minimum of 2 years of experience in regulatory affairs, preferably within the pharmaceutical industry. Strong organizational and communication skills are essential, along with the ability to work independently and collaboratively within a team environment.
The Regulatory Affairs Coordinator will prepare regulatory plans and ensure their implementation to achieve long-term objectives regarding products, collaborate with business development and marketing to establish regulatory strategies, work closely with manufacturing, quality assurance, and development sources to develop and implement labels, prepare regulatory dossiers for new products, renewals, and variations, coordinate with the logistics department for sample delivery, collaborate with marketing and medical departments on promotional materials, maintain effective communication with local representatives and authorities, ensure compliance with regulatory SOPs, relay Abbott’s corporate values, and conduct training as agreed upon.
Healthcare solutions in diagnostics and devices
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.