Danaher Corporation Specialist, Regulatory Affairs in Bangalore, India
Job Title: Regulatory Affairs Specialist
Department / Function: Regulatory Affairs
Report to / Hiring Manager: Manager RA - IDC Radiometer.
General Summary & Overall Challenges
In Radiometer’s RA/QA department we are partnering for impact to ensure reliable, fast and easy patient diagnosis in the health sector. RA/QA support the Radiometer business by ensuring compliance and quality and being and integrated partner in the organization and we help bringing innovative products to the market.
The position as Regulatory Affairs Specialist is located in Bangalore, India. Currently the team in the Regulatory Affairs Department you will become part of has 3 members in India and 2 people in Copenhagen. The position will cover IT solutions, Blood Gas, AQT and Transcutaneous monitoring devices with cooperation between R&D departments in Copenhagen and India. Your main responsibilities will be to support of R&D projects to advice on regulatory issues. This requires special knowledge within medical device and in vitro diagnostic legislations and knowledge of standards and the evolving regulations around the world.
In R&D projects you will help ensure compliant product documentation and assist in regulatory assessments, technical file and essential requirements checklist and perform regulatory activities in support of implementing device changes. As our new Regulatory Affairs Specialist, you will become part of a team specializing in supporting medical device software related tasks in the organization and also take part in building up new processes and knowledge sharing activities.
Successful execution of these tasks depends on cross-functional cooperation with QA, R&D, Production and Marketing and other departments and stakeholders. You should preferably have experience from a similar job.
II. Key Responsibilities
Core team member within R&D projects covering regulatory issues with primary focus on software
Legislation overview and being able to translate and help implement requirements in Radiometer
Help ensure sufficient documentation within appointed responsibility areas
Participate in process improvements and creation of SOPs in the RA area supporting software related topics
Gather regulatory intelligence that is relevant to Radiometer portfolio and disseminate as appropriate
III. Requirements for this position
a) Formal Education & Experience
The preferred candidate should hold a Bachelors / Master’s degree in engineering, Life science or other Technical field.
Having 8-10 years of working experince in Regulatory Affairs in Medical Devices, ideally in IVDs. in a multi-function team environment.
b) “Must Have” Competencies / Skills / Experience
Experience with medical device legislations (IVD, MD) in EU, US, China and Japan.
Experience with medical device software development and agile methodologies
Experience with working according to standards applicable for medical devices
Knowledge of regulations and guidelines for apps, cybersecurity for products and data
Use to work in development projects and have cross functional interactions
Structured person with skills for planning and visual management
Process development and lean thinking
Strong verbal and written communication skills
Experience with work relations in different cultures
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.