Specialist- Commercial Regulatory Affairs

Beckman Coulter India Private Limited; New Delhi; In loco; INR 1.500.000 - 2.100.000; Tempo pieno

Descrizione del lavoro

Beckman Coulter Life Sciences, a Danaher operating company, seeks a Regulatory Affairs Specialist to manage import licenses, renewals, and post-approval changes with a focus on India and SWA. This on-site role in Delhi/NCR requires coordinating with global teams and guiding labeling and promotional material reviews.

The ideal candidate has 7–8 years of regulatory registration experience in medical devices or IVD and strong knowledge of India MDR 2017.

Competenze

• Degree in Science, Pharmacy or related field.
• 7–8 years of regulatory registration experience in medical devices or IVD.
• Strong knowledge of India Medical Device Regulations 2017 and amendments.
• Experience in a matrix organization and international environment.

Mansioni

• Prepare and submit import license applications, renewals, and post-approval changes per country regs (focus India/SWA).
• Coordinate with Regulatory Affairs teams to gather documents for applications.
• Respond to regulator queries in a timely manner and manage project timelines.
• Collaborate with cross-functional teams for in-country testing data and labeling changes.
• Provide regulatory assessments for changes to analytics, manufacturing and packaging.

Conoscenze

Regulatory submissions

Medical devices

India MDR 2017

Analytical skills

MS Office

Formazione

Science/Pharmacy degree

Descrizione del lavoro

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 Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s 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 3,300+ global colleagues coming from the laboratory.

It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow. Learn about the Danaher Business System which makes everything possible.

The Specialist, Commercial Regulatory Affairs is responsible for preparation, submission and approvals for the Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries.

This position reports to the Manager, Commercial Regulatory Affairs (SWA) and is part of the Commercial Regulatory Affairs Center of Excellence (COE) located in Delhi/NCR and will be an on-site role.

In this role, you will have the opportunity to:

• Initiate, prepare and submit product Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries.
• Responsible for the coordination with Business Units Regulatory Affairs team in requesting documents for the applications.
• Responsible for timely responding to the queries raised by the Regulatory authority regarding the application submitted.
• Responsible for ensuring in meeting the project timelines.
• Collaborate with cross-functional departments to complete the process for the products that require in-country testing data for registration purposes.
• Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
• Provide regulatory guidance with regards to preparation, review and approval of labeling and promotional materials as needed.
• Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.

The essential requirements of the job include:

• Requires Degree in a Science / Pharmacy or related field At least 7-8 years of relevant experience within the registration process in medical devices or IVD industry and have well versed understanding of India Medical Device Regulations 2017 and amendments.
• Experience in working in a matrix organization and international environment.
• Good analytical and problem-solving skills as well as interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting; effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
• Experience in handling projects with minimum supervision.
• IT literate with MS Office.
• Multitasks, prioritizes, and meets project deadlines in a timely manner.
• Ability to work in a self-directed manner to see issues through completion.

Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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