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Regulatory Affairs Specialist (Medical Devices)

Regulatory Affairs Specialist (Medical Devices)

Siemens Healthcare

4 - 5 years

3 - 4 Lacs

Bengaluru

Posted:22 hours ago| Platform:

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Skills Required

Medical devices HP data protector Compliance Product life cycle management Siemens Healthcare data privacy Risk management Regulatory affairs Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Do you want to contribute to the future of healthcare As Siemens Healthineers values those who dedicate their energy and passion to this cause, our company s name is dedicated to our employees. It s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer.

We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting

Then come in and join

India team as Regulatory Affairs Specialist.

Your tasks and responsibilities:

Planning and preparing product related medical device submissions for the products manufactured at the Bangalore factory according to country specific regulatory requirements and maintaining of licensed products (e.g., for USA, EU, India, Latin America, Asia)

Take responsibility for product / component registrations following respective standards such as BIS, AERB, CDSCO for the products used at the Bangalore factory
You will provide professional advice to and actively support internal departments, such as product development in implementation and fulfillment of the applicable regulatory requirements (laws, guidelines, regulations) to ensure the registration of the products manufactured.
Supporting the audits from the respective authorities of the different countries as a part of the product registration process

Your qualifications and experience:

You have a diploma or degree in engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures
You have 4-5 yrs of experience in medical device registration.
You have knowledge of the pertinent regulatory frameworks of the EU, China, India, and Latin America. Experience regarding USA registrations would be beneficial
You have professional experience in the regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product lifecycle management

Your attributes and skills:

You show a collaborative, inspiring working style, and you can accommodate different personalities in a functional team
You have excellent written and spoken English communication skills
You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team
You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making
We win together: you are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job

Our global team:

We are a team of 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what s possible in healthcare to help improve people s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what s possible, to improve people s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.

To all recruitment agencies:

Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

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Regulatory Affairs Specialist (Medical Devices)