Danaher Corporation RA Specialist – International Registration in Bangalore, India
Position Title: RA Specialist – International Registration
Job Location: Bangalore, India
Radiometer Medical Aps develops products and solutions that help diagnose and care for critically ill hospital patients by providing fast, accurate information on a variety of parameters. On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision?
Click on the link: https://www.youtube.com/watch?v=VklR-M9tsjU
This position is for Radiometer team co-located with Beckman Coulter team at Danaher India Development Center (IDC), Bangalore.
IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 500+ associates, for multiple Danaher operating companies focusing on Diagnostics, Life Science, and Environmental and Applied Science segments. The operating companies includes Beckman Coulter, Radiometer, Leica Biosystems, Hach, Leica Microsystems, HemoCue, Videojet, SCIEX, Cepheid , IDBS, LS, PID Digital
The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly hardworking software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists.
The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility, measuring 120000 sq.ft.
This position is based out of IDC Bangalore supporting the International Registration activities ensuring Market Approvals for Radiometer Products.
In Radiometers RA/QA department we are Partnering for Impact to be a competitive advantage for reliable, fast and easy patient diagnoses.
The international registration team is growing rapidly. Today the team consists of 18
engaged colleagues with global representation in UK, Russia, Kazakhstan and Australia, a team of 4 in Poland, as well as 10 colleagues including the Global Director in Denmark. It is a true global team that works together across borders in RA and with key partners in the organization. The team members background lies within Pharmacy, Biology, Chemistry, and Biomedical/Medical Engineering. The international registration team is part of the Global RA team that consists of 6 teams with representation in 7 different countries with approximately 50 employees in total.
We are expanding our activities in Radiometer subsidiary in India and are therefore seeking an experienced person to take up the position as RA specialist for international registration covering India and other countries in the Asian region.
Responsibility area is to ensure market approvals for Radiometers different product areas such as Immunoassays, Transcutaneous Monitors, Samplers, IT Solutions and the Blood Gas products – this requires special knowledge within In Vitro Diagnostics- and Medical Device legislation.
Successful execution of this task depends on cross-functional cooperation with Global RA, Sales and other departments. Together with our local sales companies we are responsible for preparing and compiling regulatory dossiers to ensure that their content is in accordance with internal and external guidelines and maintain current market approvals and documentation. You will also be responsible for coordinating registrations with consultants and build up key relationships and proper stakeholder management.
This position reports to Manager, RA in Radiometer India Development Center Bangalore.
Compiling regulatory files for specific products according to regulatory requirements – as prioritized in a quarterly business intake meeting
Submission to global regulatory authorities, obtain regulatory approval, including responding to questions from authorities, as relevant including communication with local representation
Electronic archiving, keeping regulatory systems and databases up to date
Responsibility for RA product life cycle for appointed countries. Communication liaison to local RA for selected countries (responsible for regional meetings)
Participate in process for Regulatory Intelligence, assessing potential impact of new or changed regulations, process improvements, creation of SOP’s in RA area
Execute plans, complete tasks according to priorities and business goals and strategies
Competencies / Skills / Experience
The Ideal candidate shall hold a Bachelors / Master’s degree in engineering, Medical / Bio Medical or other science related field.
Having 3 -5 years of working experience in Regulatory Affairs in Medical Device industry, ideally in IVDs.
Experience with the medical device legislation - IVD, MD.
Has a proven track record of compiling regulatory files and achieving approvals
Knowledge of international regulatory legislations and terminology
Experience with labelling requirements to Medical devices and IVD medical devices.
Knowledge of the Registration relevant guidelines / directives / regulations
Travel (required estimated % of time)
- The position does not require a lot of travelling but some weeks during the year must be expected. Travel to Denmark for training purposes and/or meetings.
Why is this position an attractive opportunity ?
- Exposure to International Regulations and Registrations. Being constructive and pro-active towards Regulators/Authorities.
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Equal Opportunity Employer
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail email@example.com to request accommodation.
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