Regulatory Affairs Specialist (Medical Devices)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

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 mothers, female executives, and scientists.

A healthy heart and circulatory system are essential to good health. That's why at Abbott, we throw our hearts into advancing treatments for people with cardiovascular disease.

We are looking for Regulatory Affairs Specialist to participate in providing regulatory and quality documentation to the respective EMEA Regulatory Authorities in the region to support variations and changes to existing product registration approvals.

What You’ll Do

• Work with Business Unit RA colleagues, EMEA RA Managers, and EU MDR Project Leaders to obtain required documentation arising from CE marking of medical devices under the EU MDR.
• Prepare and submit regulatory files and documentation to Regulatory Authorities in accordance with local EMEA country regulatory requirements
• Where notification of placing on the market is required, support the local Commercial Organization and EMEA RA by submitting documentation needed to meet local requirements.
• Liaise with the Abbott Business Unit Regulatory Affairs / Quality Assurance / Regulatory Compliance Departments as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
• Liaise with the International RA Department staff. Implement databases and tracking tools to ensure projects, commitments and reporting requirements are adhered to.
• Provide metrics and feedback to management as required to enable tracking of regulatory activities in support of MDR impact analyses and implementation in EMEA.
• Support products changes and impacts resulting from the EU MDR, including but not limited to re-branding, tender and reimbursement activities by providing appropriate regulatory and quality documentation as required.
• Support and assist the local EMEA RA / Regional Manager to implement to ensure no business interruption arising from the implementation of the EU MDR.

Key Requirements

• Educated to degree level in a science discipline or equivalent. Experience of working in a regulated environment, preferably in medical devices is required.
• Some experience or knowledge of compliance activities and adherence to quality management systems requirements is desirable.
• Some knowledge or experience of product registration activities and/or European CE marking requirements and basic understanding of the new European Medical Device Regulation would be considered advantageous.
• Knowledge and experience of the application of regulations relevant to the Medical Device Industry. Awareness of the role and remit of Local Regulatory Authorities.
• Upper-Intermediate English.
• Competent user of Microsoft Office packages. Capability and strong working knowledge of Excel is desirable.
• Good communication skills. Critical thinking and the ability to challenge appropriately.
• Strong attention to detail. Highly organized, efficient and ability to meet deadlines.
• Must be a team player, with the ability to work independently. Flexibility and the ability to cope with varying workload and demands as required.
• Must be able to work with integrity and in compliance with internal company policies and external regulatory requirements.

Outstaffing in Ancor.

The stated job description, as well as the list of job requirements, is not complete.

This position opens for staff replacement.