Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

• Lead Compliance role with diversified functional focus
  
• Regional and global exposure
  
• Flexible work environment
  

The License to Operate (LTO) Partner is responsible for securing the affiliate’s foundation to be compliant with global guidelines as well as local laws and regulations. LTO Partner will:

• Promote high standards of integrity throughout the organization and ensure alignment with internal and external policies and guidelines.
  
• Foster a compliance culture through training, monitoring and proactively addressing compliance issues.
  
• Lead projects to further improve processes and process efficiency in relation to ‘license to operate’
  
• Being an advisor and thought partner that enables informed strategic choices within an acceptable general compliance risk profile
  

Key Responsibilities:
In scope for the ‘License to Operate Partner’ are Regulatory, Data Privacy, Healthcare Compliance, Information Compliance. As an LTO Partner, you will have a few key areas to focus on:

Healthcare Compliance

• Ensuring compliance with global standards/ guidelines (e.g. Code of Conduct, Directives, SOPs) directives as well as local laws and regulations including MTANZ
  
• Defining and maintaining local healthcare compliance policies/SOPs/guidelines according to regulatory environment and global/regional directives and policies
  
• Serving as a subject matter expert on compliance matters, providing guidance and training to employees at all levels
  
• Overseeing compliant interactions and behaviors to ensure our license to operate, including cooperation with distributors and business partners
  
• Supporting compliance investigations, due diligence and internal audits
  
• Acting as the Local lead for Compliance Evidencing Platform (CEP)
  

Information Compliance

• Working across all functions to build information compliance requirements into governance processes
  
• Acting as a primary information compliance contact and co-ordinates information compliance representative
  
• Initiating the evaluation of selected systems against Coremap standards
  

Regulatory Affairs

• Proactively identifying internal and external environmental changes and other dynamics; assessing business implication for development of strategic and tactical plans
  
• Working with relevant global, regional, local teams; point of contact for Region and Global on regulatory matters
  
• Ensuring Regulatory Affairs systems are updated with current regulatory activities, timelines and priorities
  

Data Privacy

• Supporting Data Privacy Officer in all matters relating to Data Privacy, e.g. with creating awareness, monitoring, training, administrative tasks around reporting
  

Who you are:
You are a qualified Compliance professional with:

• Experience in compliance and risk management
  
• Experience in the diagnostics, medtech and healthcare industry (preferred)
  
• Expert knowledge of Industry Codes of Conduct and other relevant standards and guidelines
  
• Project management and process improvement experience
  
• Broad knowledge of international business practice, trade and commercial policies, medical device regulatory frameworks and requirements
  

With a problem solving mindset, you are able to:

• Communicate in a concise and clear manner that supports expeditious and effective decision-making
  
• Speak directly even on controversial issues
  
• Demonstrate a “Can-do” attitude
  
• Establish common ground with stakeholders, balancing out conflicting interests and reaching consensus
  

Being a self starter and entrepreneurial you enjoy creating and implementing new initiatives. With your strong influencing skill, you can influence without authority and have proven experience building and cultivating effective relationships with key stakeholders.

This role is only open to candidates that have full eligibility to live and work in New Zealand.

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.
Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes.

We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.