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Associate Director Regulatory Affairs Strategy

Job in Machelen - Belgium
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Company: Abbott
Full Time position
Listed on 2021-04-22
Job specializations:
  • Pharmaceutical
    Pharmaceutical Manufacturing, Pharmaceutical QA
  • Science
Job Description & How to Apply Below
Position:  Associate Director Regulatory Affairs Strategy (M/W)
As an individual contributor, the role of Associate Director, Regulatory Affairs in Abbott’s corporate Global Strategic Regulatory department is to combine knowledge of scientific, regulatory and business issues to support Abbott’s businesses and Regulatory Affairs teams in Europe/Middle East/Africa (EMEA) Region. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally.

Responsibilities include:

Identifying regulatory changes that may impact Abbott’s businesses and working collaboratively with cross-functional teams to develop strategies for advocacy and implementation;

Providing strategic direction and technical guidance on EU MDR and IVDR regulatory requirements to ensure robust technical files and timely CE-marking of device and diagnostic products;

Engaging externally with regulatory agencies and trade associations;

Managing moderately complex regulatory projects impacting more than one Abbott business;

Providing strategic guidance to senior management and functional organizational leadership; andServing as a regulatory subject matter expert throughout the product lifecycle.

What will you do?

The Associate Director EMEA must possess strong knowledge of the regulation of devices and in vitro diagnostics in the EMEA region and is responsible for leveraging that expertise to support Abbott’s regulatory objectives in the region.

Experience with drug and/or nutrition regulatory requirements is a plus.

This position has high visibility externally and as such has the potential for influencing the perception of Abbott. This individual operates with only general direction and supervision from the Senior Director, Regulatory Affairs for EMEA. Decisions are made which fully support the direction agreed to by management to ensure timely accomplishment of goals. Given the broad scope of responsibility, this individual must be able to effectively influence and guide a diverse stakeholder base, spanning across functional and divisional boundaries. 

Who are you?

Minimum of 5 years regulatory experience;

Knowledge of project management tools, Excel and SharePoint;

Regulatory knowledge of:

Regulations and standards affecting medical devices, in vitro diagnostics, and biologic products with international regulatory frameworks;

High-level familiarity with nutritional and pharmaceutical regulations;

Regulatory agency structure, processes and key personnel; andEthical guidelines of the regulatory profession, clinical research and regulatory process.

Experience supporting ISO/ EU inspections;

Experience successfully working with regulatory agencies, including responding to agency requests/issues;

Experience working with Notified Bodies on product submissions;

Experience working with trade associations and other industry groups;

Ability to work across organizations and management levels, work across boundaries and diverse cultures;

Excellent communication skills (oral and written), strategic thinking and planning skills, leadership presence;

Desire to cultivate an open, trustworthy, credible environment that gains the respect of peers and colleagues inside and outside the organization;

Must have the ability to handle multiple projects in fast-paced environment and exercise sound judgment;

Must be able to independently handle moderately complex matters with minimal supervision and understand which issues to elevate to senior management and appropriate timing for doing so; andMust be able to analyze complex issues, develop pertinent strategic proposals and policies, identify business opportunities, and make sound, relevant recommendations as to possible alternatives to achieve business objectives. The preferred location of this position is in Brussels, Belgium area.

Abbott is an equal-opportunity employer.
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
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