LivaNova
Join LivaNova and make a real impact in patients' lives! With nearly five decades of experience, LivaNova is a prominent global medical technology company dedicated to enhancing the health of people around the world through innovative technologies and breakthrough treatments. We're listed on NASDAQ under the ticker "LIVN" and are headquartered in London, UK, with operations in over 100 countries and a talented workforce of more than 3,000 employees.
Key Responsibilities:
As a Lead Regulatory Affairs Specialist, you will play a vital role in preparing comprehensive regulatory submissions (including 510(k), IDE, IDE Supplements, PMA, PMA Supplements, CE Marking, etc.) to the FDA and equivalent international regulatory bodies. Your expertise will also support the corporation's quality objectives and compliance with GMP and ISO standards.
Your Primary Activities Include:
Developing regulatory submissions for the FDA and international agencies, with a focus on Canada and the EU.
Engaging with regulatory agencies throughout assigned projects.
Addressing requests for additional information from regulatory authorities.
Facilitating export clearance requests according to regulatory requirements.
Collaborating with regulatory agencies during quality inspections and preparing necessary reports.
Staying updated on global regulatory changes impacting our products and processes.
Communicating changes or initiatives regarding medical device laws with internal teams, partners, and regulatory contacts.
Reviewing QSR documentation to ensure compliance and identifying necessary regulatory submissions.
Maintaining regulatory files to uphold compliance standards.
Managing the approved products database.
Assisting with special research tasks as needed.
Performing additional duties as assigned by management.
Experience and Skills Needed:
Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Deep understanding of U.S. and international regulatory requirements.
Exceptional verbal and written communication skills, along with analytical prowess and teamwork abilities.
Adept in conducting regulatory research across various platforms.
Familiarity with Acrobat and AutoCAD.
Experience with ISO 9000/QSR guidelines.
Previous experience working with the FDA is a plus.
Background in sleep apnea therapy or neuromodulation implantable devices is valuable.
Education Requirements:
Minimum of a master's degree in biomedical engineering, science, or a related technical field along with at least 8 years of relevant experience in medical writing and regulatory affairs.
Travel and Physical Requirements:
This position may involve occasional travel (10% or more). You should be able to perform essential job duties, including work in an office environment involving computer use and communication.
Salary and Benefits:
An estimated annual base salary for this position ranges from $100,000 to $125,000, plus a discretionary annual bonus. Benefits include comprehensive health coverage (medical, dental, vision), generous personal and vacation time, a 401K retirement plan, an employee stock purchase program, and various training and education support.
Commitment to Diversity:
LivaNova is committed to fostering an equitable and diverse work environment. We ensure that our recruitment processes are fair and free from discrimination based on various protected characteristics.
Application Scams Awareness:
Please be cautious of fraudulent job postings or recruitment activity. LivaNova will never ask for personal or financial information during your application process. For verification of our job offers, please check our careers page for open positions directly.