Regulatory Affairs Professional

Company : Siemens

Job Type : Full Time

Bengaluru, Karnataka

Number of Applicants

000+

Let AI Supercharge Your Job Hunt!

JobCopilot scans 500,000+ company career sites daily to find jobs for you

Never miss an opportunity Save hours by auto-filling applications forms Land more interviews with tailored applications

Activate JobCopilot

Job Description - Regulatory Affairs Professional

ce: 5-8 yrs

Qualifications:

You have successfully completed a course of studies in a technical or clinical field, preferably in engineering, medicine, medical engineering or (medical) informatics

You can offer extensive professional experience in regulatory affairs for Software as Medical Device, SaaS, and/or cloud deployments

You have a sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD/MDR, 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)

Your profile also includes a knowledge of regulatory requirements for the clinical evaluation of software for medical devices

Experience in process or quality management would be an advantage

Your Attributes And Skills:

You are business-fluent in English, enabling you to operate successfully in our international context; knowledge of German would be an advantage

Your personal qualities include a professional approach, skills in planning and organization, and cross-cultural experience

You also have team and communication skills, initiative, and a structured, target-oriented way of working

You champion the success of Siemens Healthineers with drive and passion

Roles and Responsibilities:

Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold.

Maintaining a good understanding of new and existing regulations, standards and guidance that may impact their organization’s products and processes.

Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary.

Able to work in cross functional teams with good communication & interpersonal skills

Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals.

Prepare submissions for regulatory registration and renewals

Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency

Preparing for and supporting internal, regulatory, and third-party audits as necessary

Original job Regulatory Affairs Professional posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.

Auto-Apply to Similar Jobs

Share Job

Get your Resume Reviewed for Free

Automate Job Applications for Similar Jobs

Auto-Apply to Regulatory Affairs Professional Jobs with your AI JobCopilot

Auto-Apply with AI

Similar Regulatory Affairs Professional Jobs in India

Get your Resume Reviewed for Free

Email address

Why are you reporting this job?

I think it’s a discriminatory or offensive

I think it’s fraudulent or a scam

I think it’s trying to sell something unrelated to the job / it’s asking for money

I think it contains incorrect or broken information

Other

All Job Ads are subject to GrabJobs’s Terms of Service. We allow users to flag postings that may be in violation of those terms. Job Ads may also be flagged by GrabJobs moderation team. However, no moderation system is perfect, and flagging a posting does not ensure that it will be removed.

Setup your job alert:

Frequency

By activating job alerts, I agree to GrabJobs Terms & Privacy Policy. I can unsubscribe to job alerts anytime. Skip

Regulatory Affairs Professional

Job Description - Regulatory Affairs Professional

Similar Regulatory Affairs Professional Jobs in India

Mobile Apps