Regulatory Affairs Specialist

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. As a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Chapter, you will be a member of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT). In this position, you will be a leading figure and key point of contact for Roche Diagnostics’ regulatory capabilities in Lab Coagulation and Clinical Chemistry. You will improve the subchapter’s overarching expertise based on current and upcoming needs to deliver on network priorities (e.g. upcoming portfolio investments with new technology skills needed). Your Opportunity You develop and coach 10-15 Regulatory Affairs staff to enable the greatest impact for our customers. You nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics’ efforts with best-in-class expertise You act as subject matter expert with the US FDA, Notified Bodies, international regulatory agencies and other regulatory bodies to advance project objectives. You monitor the global regulatory environments, and provide staff and stakeholders with assessments of the impact of new and changing regulations. You are responsible for effective resource management across the team, in alignment with the respective Lifecycle teams. You drive process standardization and reuse where it makes sense (common assets, technical standards) balancing creativity and innovation You enable the organization’s New Ways of Working by acting as Role-model for Agile Leadership behaviors, as well as for our culture, and mindset as defined in View email address on click.appcast.io You are committed to cross-functional collaboration and breaking down silos to achieve the best results for the organization. You navigate within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skills Who You Are You have a Bachelor or Advanced degree in science or a related field You have a general understanding of the Diagnostics industry, lifecycle & development process and global trends You have 7+ years of experience in Regulatory Affairs within the diagnostics industry or a related field with knowledge of IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP’s and QSR’s, ISO13485 and 2701​. You have experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China, preferred) You have a strong track record of building and nurturing capabilities such as technical regulatory knowledge, strategic thinking, verbal and written communication and stakeholder management You have a history of successful interactions with regulatory bodies Leadership and People Development: You have the ability to lead with a creative attitude, very high self-awareness and being a coach and a mentor to other leaders and partners You demonstrate the ability to build networks and can inspire to work agile You show empathy towards the needs of Squads and other Chapters combined with skill of prioritizing resource involvement You have demonstrated success in establishing a high performing environment with an excellent reputation attracting the best talent, developing and inspiring them You can define career progression and development capabilities for Regulatory Affairs in networked organizations Locations: You can be based in Indianapolis, Penzberg, Mannheim, Rotkreuz, Motherwell, Branchburg, Tucson, Pleasanton, Santa Clara, or Carlsbad. Relocation benefits are not available for this position. As this position is a global role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities. The expected salary range for this position based on the primary location of Indiana is $111,200 and $258,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Indianapolis. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr