Senior Specialist Regulatory Affairs, Nordics

Job description

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Opportunity:

Based out of Sweden we are looking for a Senior Specialist Regulatory Affairs to cover the Nordic region.

What You'll Do:

·  Participate in the development of a regulatory strategy for new and existing devices together with regulatory affairs management, considering the interests of the company and regulatory requirements.
·  Support new product introductions, tender and reimbursement activities by providing appropriate regulatory and quality documentation as required in accordance with established formats and deadlines.
·  Monitor new regulatory requirements related to the medical devices in the Nordics
·  Liaise with Abbott International and Business Units as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
·  Implement databases and tracking tools to ensure projects and commitments are adhered to.
·  Provide metrics, reports and feedback to management as required to enable tracking of regulatory activities.
·  Support Senior Management and leaders as required, to meet local business objectives in line with agreed objectives.
·  Review and approve locally generated advertising and promotional (A&P) materials
·  Manage and maintain a strong relationship with the National Competent Authorities in the Nordic region.
·  Ensure adherence to company policies and procedures.
·  Keep up to date with and communicate on requirements of the local legislation and guidance in the Nordics relating to medical devices and ensuring their safety.

Qualifications:

·  Educated to degree level, preferably within a scientific area (medical, pharmaceutical, biomedical engineering) or equivalent.
·  Knowledge of Nordic regulatory requirements for medical devices is required.
·  Minimum 2 years’ experience in a similar role in regulatory affairs or clinical covering the Nordic region in a regulated environment is required, and preferably in the medical devices/healthcare sector.
·  Experience of working within the context of a certified Quality System and regulated environment is desirable.
·  Fluent in Swedish and English any other Scandinavian language is a plus.
·  Ability to show initiative and interact effectively with colleagues.
·  Excellent teamwork and focus on achieving business goals.
·  Excellent communication and negotiation abilities.
·  Good attention to detail and strong analytical skills are needed to perform this role effectively.
·  Ability to develop some technical understanding of Abbott medical devices.
·  Task oriented and a completer / finisher.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

·  Career development with an international company where you can grow the career you dream of
·  A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
·  A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working parents, female executives, and scientists.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

Sweden > Kista : Isafjordsgatan 15

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable