RA Operations Specialist

Remote       ·       Full time

Full Job Description

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

This position is responsible for:

• administration of global processes for the monitoring, control, and communication of external documents applicable to LivaNova medical devices (e.g. international standards, medical device laws and regulations, regulatory guidance);
• administration of global processes for the control and maintenance of promotional material for LivaNova medical devices.
• providing oversight and subject matter expertise for global UDI processes; administers local UDI processes for NM and ACS product lines;
• understanding and ensuring compliance with regulations, standards, and regulatory guidance for the control, approval, and maintenance of the outputs generated by these processes.

Primary Activities

• Responsible for execution of global external documents process, including periodic screening meetings and associated tasks
• Provides oversight of the global promotional material process to ensure content creators and reviewers follow processes and use appropriate tools
• Responsible for support of global UDI processes, including the adaptation of systems for future UDI regulations
• Responsible for DI assignment and control and associated manual regulatory database submissions for Houston and Pittsburgh
• Responsible for other global regulatory operations support as defined by management
• Identifies and drives efforts for continuous improvement
• Identifies procedures and best practices for information development and localization processes

Additional Activities

• Performs other related duties and responsibilities, on occasion, as assigned

Financial Expenditures/Commitment Levels

This position is authorized for financial expenditures/commitment levels as defined by the Neuromodulation Business unit, Inc. Global Authority Matrix.

Travel Requirements

This position may require business travel.

Minimum Requirements And Qualifications

• Education: Bachelor’s degree (or equivalent) in social sciences, communications, business, engineering or science
• Education & Experience Levels
  • Level 1: Bachelor’s degree and 0-2 years’ experience
  • Level 2: Bachelor’s degree and 3-5 years’ experience; or Advanced degree and 0-2 years’ experience
  • Level 3: Bachelor’s degree and 5-8 years’ experience; or Advanced degree and 3-5 years’ experience
  • Level 4 (senior): Bachelor’s degree and 8+ years’ experience; or Advanced degree and 5+ years’ experience
• Knowledge and understanding of UDI regulations and industry standards, such as GS1 Specifications
• Knowledge and understanding of medical device related standards used medical device quality systems, and in the design, development, and distribution of medical devices
• Knowledge and understanding of medical regulations, laws and guidance for promotional materials
• Strong research and organizational skills
• Resourceful, creative, well-organized with an ability to prioritize and proactively offer solutions
• Ability to work effectively within a team in a fast-paced changing environment
• Ability to work in a highly matrixed and geographically diverse business environment
• Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Prioritizes and meets deadlines in a timely manner
• Proficient in MS Office tools (Outlook, Project, PowerPoint, Word, and Excel)
• The minimum requirements, skills and qualifications contained in this job description outline the core functions and requirements of the position and do not constitute an exhaustive listing of activities, duties, or responsibilities that may be required of or assigned to an employee in this position at the Company’s discretion. Further, the ability to meet the minimum requirements and/or possession of the stated skills and qualifications do not imply or establish that an individual will be employed in this position.

Desired Skills And Qualifications

• Significant experience working in a broader enterprise/cross functional business preferred
• Advanced university degree in any of the disciplines listed above
• Experience in regulatory affairs
• Experience in standards development

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.

Background Checks at LivaNova:

Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check. This process is not currently valid in Germany.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

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