EndereçoAbbott 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.
