Senior Manager, Regulatory Affairs

Join us today and make a difference in people's lives!
 

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:

The Senior Manager, Regulatory Affairs leads the strategic development, implementation  and maintenance of the Regulatory Affairs functions to support Product Development, Clinical, Manufacturing, Marketing, and other Quality System activities. 

General Responsibilities:

Functional responsibilities of this position include:

• Participates on project teams for purposes by identifying regulatory requirements for market approval (e.g. PMA, PMA supplements), clinical trials (IDE, IDE supplements) and pre-submission.

• Acts as primary interface with Regulatory Agencies (FDA, EU notified body, HCAN) for medical device registration activities.

• Writes summary technical reports for regulatory submissions

• Develops regulatory submission applications for introduction of new or modified devices, new or expanded indications for use or changes to the manufacturing/quality processes.

• Plans for and orchestrates meetings with regulatory officials for purposes related to market approval.

• Provides senior management practical operations-oriented interpretation of Regulatory requirements governing medical devices.

• Participates on the review and approval of advertising and promotional literature.

• Leadership and development of direct reports.

• Maintains regulatory files to ensure the Company’s compliance with regulatory requirements.

• Defines and implements initiatives to enhance efficiencies, productivity, and quality that are consistent with company changes and growth.  Supports and implements such changes without adversely impacting quality or regulatory compliance. 

• Develops, reviews and approves 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. 

• Collaborates with Operations to define and implement systems that enhance efficiency, productivity and quality.

• Collaborates with Clinical Affairs, R&D, Quality, and Operations to fulfill design control activities and other Product Development Projects/New Product deliverables as defined.

• Ensure national requirements are met prior to distribution.

• Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.

Skills and Experience:

• 8+ years of relevant experience in the medical device industry, including regulatory experience directly related to Class III active medical implants.

• Experience with connected care products (SaMD).

• Proven track record of a leadership role in development and implementation of clinical, or regulatory processes and procedures.

• Understanding of basic clinical and regulatory principles including, but not limited to leadership, coaching and motivational skills, project management skills, strategic planning and organizational skills, clinical trial design and methodology and knowledgeable of world-wide clinical and regulatory environments we compete in.

• Ability to prioritize and plan activities of self and direct reports.

• Resolves most issues with peers, but understands what issues are important to escalate to senior management. 

• Possesses appropriate knowledge of pertinent regulations in major jurisdictions (Europe, U.S., Canada) to assure regulatory submissions  and  the  departments  procedures  meet  these  requirements  and,  when  necessary,  identify  compliant,  effective and efficient approaches to fulfill such requirements.

Education:

• A minimum of a B.S. in Engineerin