1+ months
2018-06-062018-11-11

Senior Regulatory Affairs Specialist

Abbott
Green Oaks, IL 60048

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

***Position can be based at Alameda, CA (HQ) or at our new manufacturing facility in Buffalo Grove, IL.

This new Senior RA Specialist position at ADC will focus on manufacturing capacity expansion projects for our FreeStyle Libre product family from a regulatory affairs perspective. Pre-market Approval (PMA) supplement and change management experience is crucial.

     

Position Summary

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.  The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.  The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

This is a broad scoped position with strong opportunity for growth and career development.

Qualifications

At least three (3) years of regulatory affairs experience within medical devices, ideally with class III PMA products.

Main Responsibilities

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.

The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.

The individual may prepare or oversee such preparation documentation needed for registration worldwide.

Assist in SOP development and review 

Provide regulatory input to product lifecycle planning.

Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

Assist in the development of regional regulatory strategy.

Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

Determine trade issues to anticipate regulatory obstacles.

Determine and communicate submission and approval requirements.

Participate in risk benefit analysis for regulatory compliance.

Assess the acceptability of quality, preclinical and clinical documentation for submission filing.

Compile, prepare, review and submit regulatory submission to authorities.

Monitor impact of changing regulations on submission strategies.

Monitor applications under regulatory review.

Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Assist compliance with product post marketing approval requirements.

Review regulatory aspects of contracts.

Assist with label development and review for compliance before release.

Submit and review change controls to determine the level of change and consequent submission requirements.

Provide regulatory input for product recalls and recall communications.
Job Family: Regulatory Operations
Division: ADC Diabetes Care
Travel: Yes, 10 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Senior Regulatory Affairs Specialist

Abbott
Green Oaks, IL 60048

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