Michael Page
Job description / Role
This role provides Regulatory Affairs support for the EMEA region (Europe, CIS/Russia, Middle East, Africa, Turkey, Indian Subcontinent). Provides advisory support to marketing, sales, operations and other company stake holders. Managing regulatory submissions (new and renewals) in compliance with local country requirements and internal standards of our client. Contribute to day-to-day requests from Sale and Marketing colleagues.
Client Details
Medical devices company
Description
* Support EMEA regional business by providing RA support to Marketing, Customer Service & Sales w.r.t queries, assistance in tenders, provision of regulatory documentation etc
* Plan and coordinate the requirements for compiling technical dossiers as part of regulatory submissions for new product registration and renewal of existing registrations.
* Communicate all requirements to manufacturing sites and global Regulatory Affairs team.
* Track and follow up in a timely manner to ensure deadlines are met.
* Providing the required support for distributors in local markets to ensure regulatory compliance with local legislation requirements.
* Address gaps and plan for any remediation where appropriate.
* Review all technical documentation, product labels and user instructions to ensure compliance with each country’s regulations.
* Creating and maintaining tracking process and reporting tools for all QA/RA tasks, including registration file submissions, approvals, renewals, projects and tender requests.
* Identify post market vigilance and surveillance requirements specific for local market in EMEA
* Support preparation of Regulatory Submissions for countries in EMEA region. Communicate all requirements to manufacturing sites and global Regulatory Affairs team.
* Track and follow up in a timely manner to ensure deadlines are met.
* Gather and disseminate regulatory intelligence information that affects regional registrations/compliance.
* Manage regulatory aspect of Product Life Cycle by ensuring updated and obsolete products are handled appropriately internally and externally.
* Advise the business in regulatory requirements.
* Implement framework and tools throughout EMEA region, Emerging Markets business locations
* Other duties may be assigned
Job Offer
* Join a multinational company
A challenging position with a large geographical cover !
