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Nobel Biocare
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Nobel Biocare

3 - 7 years

7 - 11 Lacs

Mumbai

Posted:1 day ago| Platform:

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Skills Required

Medical devices Claims Literature Staffing Talent acquisition Pharma HR Regulatory affairs Auditing Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Regulatory Affairs (RA) Specialist is responsible for supporting the Regulatory Affairs department in global submissions, registrations, approvals, and audits; especially as it relates to footprints projects and sustaining activities. This is a great learning opportunity for someone interested in a Regulatory Affairs career in medical devices. Will train an enthusiastic, eager learner with a team attitude and passion for medical devices and helping patients thrive.

PRIMARY DUTIES & RESPONSIBILITIES:

Supports footprints projects with the ability to multi-task
Assembles and submits documents for global registrations with direct oversight from the RA team
Ensures all deadlines are met, paying particular attention to any government deadlines
Collaborates with other departments to gather documentation needed for global submissions
Responds effectively and timely to internal and external partners
Tracks submissions and maintains applicable dashboards
Prepares weekly reports on status of current items/issues to manager
Organizes and maintains files, folders and databases to support the integrity of regulatory documentation
Orders documents, subscriptions, articles, standards and other items; including Free Sale Certificates and Certificates to Foreign Government
Coordinates audits as needed
Coordinates notarization and authentication (legalization) of documents
Coordinates shipment of documents (UPS, etc) and may also be responsible in coordinating samples
Prepares data for audits, as needed
Reviews publications to keep abreast of regulatory landscape for medical devices
Performs special projects at the direction of the Regulatory Affairs Management
May assist in the regulatory review of product claims and literature

Job Requirements:

REQUIREMENTS:

bachelors degree in a related field plus 2 years of relevant work experience required, preferably in the Medical Device or Pharmaceutical industry or technical field.

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Nobel Biocare

Medical Equipment Manufacturing

Zurich Kloten

1001-5000 Employees

17 Jobs

Key People

Rainer K. Schmitt

President
Marina G. Rinaldi

Director of Global Marketing

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Regulatory Affairs Specialist