Danaher Corporation Regulatory Affairs Specialist (12 months contract) in Bryanston, Gauteng, South Africa
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Regulatory Affairs Specialist assists with the preparation of regulatory submissions. This includes identifying product registration requirements, compiling and organizing materials for communications with global health authorities and/or in-country representatives.
In this role, you will have the opportunity to:
Identifies information sources and resources for local regulations.
Collects and coordinates information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.
Assist in device registration activities - agency communication; registration requirements; participation in submission document preparation.
Maintain files on local, regional and global regulatory intelligence and other related information.
Track the status of applications under regulatory review and provide updates
Helps prepare technical documentation, pre-market authorization applications and change notifications.
Generate regulatory reports to communicate local registration activities.
Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives.
Get along with RSA regulatory leaders and peers to expedite approval of pending registrations.
Interact with departments to generate protocols and reports that require in-country testing data for registration purposes.
Maintain a "focused vitality" as the need arises by specific events.
Recognize problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.
Prepare written reports, PowerPoint presentations, and documents for distribution within work unit and regions.
Provide training and coordinate with department personnel from regulatory, quality, and manufacturing sites, Sales and Marketing.
Organizes and maintain RA files such as Responsibilities Matrix, Certificates from Notified Bodies (CFS and CFG) and other RA related material. Ensures that existing approvals and documentation are maintained.
The essential requirements of the job include:
Good organizational skills with attention to detail and accuracy.
Ability to work independently in a fast-paced environment with flexibility to manage changing priorities.
Able to demonstrate a broad experience of manufacturing processes and equipment.
Interprets subjective and intricate aspects of specific regulations and has detailed understanding of multiple sets of associated regulations.
Able to confidently deal with ambiguous issues and provide input towards suitable actions.
Demonstrated excellence in communicating and presenting complex information to technical and non-technical partners.
Proven ability to manage and prioritize multiple projects. Highly motivated, takes initiative, follow through, and complete projects in a professional and timely manner.
IVD product experience is highly preferred.
Prior knowledge of different databases like SAP, Sales Force, Tarius, Trackwise etc. including Agile documentation system is a bonus.
Understands Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products.
Excellent oral and written communication and presentation skills. Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
Bachelor’s degree with 0-2 years of related work experience.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid