Principal Regulatory Affairs Specialist - LivaNova : Job Details

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LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol “LIVN.” LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

Position Summary: With a high degree of autonomy performs quality work of a broad nature to achieve successful outcomes of departmental and company objectives. The US RA Principal Specialist guarantees all activities needed for obtaining approvals and keeping them up to date in the North America (mainly) and EU market area as well as the development of the regulatory affairs activities deriving from the mission of the company in compliance with the company quality system and the international regulations governing medical device manufacturing and distribution.

General Responsibilities:

• Participating on project teams to provide input to ensure that appropriate regulatory requirements for market clearance or clinical trials are built into project plans.
• Summarizing technical documents for regulatory submissions.
• Developing regulatory submission applications to introduce new or modified devices, new or expanded indications for use, or changes to the manufacturing/quality processes into the marketplace.
• Participating in meetings with regulatory officials for purposes related to market approval.
• Providing senior management practical operations-oriented interpretation of regulatory requirements governing medical devices.
• Responding to registration requests from regulatory authorities.
• Maintaining regulatory files to ensure the company's compliance with regulatory requirements.
• Implementing initiatives to enhance efficiencies, productivity, and quality that are consistent with company changes and growth without adversely impacting quality or regulatory compliance.
• Developing and reviewing quality system documentation such as Clinical and Regulatory strategic plans, procedures, verification and validation protocols and reports, investigation (e.g., complaint or CAPA) and clinical protocols and study reports.
• Collaborating with Operations to define and implement systems that enhance efficiency, productivity and quality.
• Collaborating with Clinical Affairs, R&D, Quality, Marketing and Operations to drive best practices into project and fulfill design control activities and other Product Development Projects/New Products deliverables in a timely manner.
• Ensuring national requirements are met prior to distribution.

Skills and Experience:

• Experience working in a regulated environment industry such as a FDA Class 2 or 3 (or equivalent international classification) medical device manufacturer.
• Deep knowledge of FDA regulatory processes including pre-submission and De Novo, to assure regulatory submissions and the department's procedures meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfill such requirements.
• Deep knowledge of Health Canada regulatory processes for class III and IV products, to assure regulatory submissions and the department's procedures meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfill such requirements.
• Appropriate written and verbal communication skills.
• Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders.
• Understanding of basic clinical and regulatory principles including, but not limited to: clinical trial design and methodology and knowledgeable of worldwide clinical and regulatory environments we compete in.
• Good team player: open and honest when communicating among peers and management. Resolves most issues with peers, but understands what issues are important to escalate to management.

Education: A minimum of a BS in Engineering, Life Sciences, Pharmacy, Nursing or Mathematics/Statistics is required.

Travel Requirements: This position may require occasional business travel of 10% or more of the time.

Compensation: The target compensation range for this position is $125,000 to $140,000 annual salary plus annual bonus. Compensation will be awarded based on prior experience.

Employee benefits include:

• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.