You will be responsible for a portfolio of cutting-edge medical devices & IVDs, leading regulatory activities for new product introductions and significant on-market changes for the Europe, Middle East, Africa and Pakistan (EMEAP) region. You will work as part of a global team, to develop, lead and implement strategies that will ensure the timely introduction of new products onto the international market in a fast‑paced environment. You will coordinate and oversee preparation of complete and scientifically sound regulatory submissions and lead interactions with the Notified Body and country regulatory contacts to facilitate the regulatory submission review process to ensure a timely approval process.
Responsibilities
- Formulate, develop and lead business critical regulatory strategies for the EMEAP region.
- Act as the regulatory subject matter expert in design control projects, assessing changes and managing roll out programs for existing products and new launches.
- Become a technical expert in ADC devices and support interactions with EU Notified Body/UK Approved Body, as well as competent authorities, as required.
- Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745, IVDR 2017/746 and other application regulations.
- Provide coaching and mentoring to more junior team members.
- Identify and implement process improvements and efficiencies per the global regulatory affairs strategy.
Minimum Experience and Qualifications
- Knowledge of MDR 2017/745 Regulations and ISO13485 is essential, and knowledge of IVDR 2017/746 is preferred.
- Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role.
- Experience of Technical File creation and maintenance, as well as post‑market changes.
- Experience of working with Notified Bodies and/or other regulatory bodies.
- Excellent written and oral communication skills necessary to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
- Bachelor's degree or equivalent preferably in a Scientific discipline (e.g., Chemistry, Life Sciences, Biology).
Benefits
In addition to a competitive salary, Abbott offers a highly attractive benefits package which includes a defined‑contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.
