Staff Regulatory Affairs Bangalore

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Beckman Coulter Life Sciences one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Beckman Coulter Life Sciences we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.

We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists with many of our 3300 global colleagues coming from the laboratory.

Its all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And were just beginning. Working together lets put our time and talents together to advance human health for tomorrow.

Learn about the Danaher Business System which makes everything possible.

The Staff Regulatory Affairs is responsible for driving compliance through Regulatory change and regulatory intelligence activities including but not limited to identification interpretation assessment and project management of changes. The purpose of this role is to maintain compliance with regulatory requirements on products and business systems and avoid audit observations and shipping delays.

This position reports to the Senior Manager Regulatory Affairs and is part of the Global Quality and Regulatory affairs team and will be fully remote.

In this role you will have the opportunity to:

Monitor and analyze global regulatory intelligence across: IVD and medical device regulations (e.g. EU IVDR US FDA regulations and guidance)AI/Software regulations Chemical and environmental regulations (e.g. EU REACH RoHS PFAS EPA EU CLP requirement)

Develop detailed assessments of regulatory changes providing actionable insights and impact analyses for internal stakeholders. Create business cases for regulatory-driven changes including cost resource and timeline impact for compliance activities.

Support global regulatory strategy development by providing intelligence-driven recommendations. Maintain regulatory intelligence repositories dashboards and communication tools.

Prepare and deliver regulatory intelligence briefings cross-functional reports and executive summaries.

Leverage AI-enabled tools to automate horizon scanning and early detection of regulation changes Lead compliance gap analyses and risk assessments to proactively identify areas of regulatory exposure and develop mitigation plans in partnership with Quality and Legal teams. Ensure alignment with internal SOPs and global regulatory standards.

The essential requirements of the job include:

Masters degree in life sciences engineering or related field; advanced degree preferred.10 years of experience in regulatory affairs or regulatory intelligence within the IVD/medical device industry.

Strong knowledge of global IVD regulations including FDA EU IVDR ISO 13485 ISO 20916 and related standards. Demonstrated experience managing regulatory compliance programs including compliance tracking systems and audit readiness activities.

Experience implementing regulatory intelligence systems or digital tools.

Experience with AI/software or chemical/environmental regulations strongly preferred

Experience interacting with regulatory agencies or notified bodies is a plus.

It would be a plus if you also possess previous experience in:

Previous experience in a regulatory intelligence role handling gap assessment and/or coordinating remediations

Beckman Coulter Life Sciences a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Beckman Coulter Life Sciences we believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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