Specialist Regulatory Affairs (Temporary) - Madrid

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Position: Specialist Regulatory Affairs (Temporary) - Madrid 

Primary Function/Primary Goals/Objectives: 

Provide support for the regulatory department to ensure efficient and compliant business processes       Prepare and submit documentation for registration/notification for medical nutrition, direct to consumer products and medical devices and reimbursement for medical nutrition.

Major Responsibilities:        

Responsible for compliance with applicable Local and Divisional Policies and procedures. Provide regulatory input to product lifecycle planning Implementation of regulatory requirements on product registration, reimbursement and promotional materials Planning and execution of the following  regulatory activities:

Ensure Regulatory approval for placing clinical nutrition products in the market, infant and adult FSMP

Ensure Reimbursement approval for placing clinical nutrition products in the market, infant and adult FSMP

Ensure compliance with all relevant statutory requirements and all relevant internal procedures

Provide Regulatory assessment for new and existing products

Nutritional products label review

Ensure registration approval for new medical devices and also for modifications

Revision and approval for all promotional materials (medical nutrition, food supplements and medical devices)

Liaison with Division Regulatory Affairs groups

Education:

• Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred

• English Level C1.

Background/Skills/Knowledge:

Does not specifically require regulatory experience.  2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Accountability/Scope:

Individuals execute and manage technical and scientific regulatory activities, understand regulations and guidance.  Individual works under minimal supervision and may independently determine and develop approach to solutions.  Work is reviewed upon completion for adequacy in meeting objectives.  Communicate effectively verbally and in writing with diverse audiences/personnel. Write and edit technical documents   Work with cross-functional teams.

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