About Us: Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. We employ over 6,000 people across ten sites in Ireland.
We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo, as well as a third-party manufacturing management operation in Sligo. Our commercial, support operations, and shared services are based in Dublin and Galway.
Abbott Nutrition: Our nutrition business develops science-based nutrition products for people of all ages. Millions of people around the world rely on our leading brands to help them live their healthiest lives.
Job Summary: As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, you will use your in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices.
The MSS Global Medical Device Manager will be responsible for generating documentation that supports Abbott Nutrition's global medical device registration and ongoing compliance with EUMDR. This may include developing and implementing global standardized operating procedures. You will also lead the development/maintenance of local medical device vigilance systems, ensuring compliance with local regulations.
Major Responsibilities:
* Organize, manage, and maintain a highly compliant global medical device system for Abbott Nutrition.
* Maintain awareness and ensure compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.
* Develop and implement training programs for individuals involved in medical device activities.
* Monitor medical device system performance; track compliance metrics and report to global MSS Leadership Team.
* Ensure global/local medical device audit readiness; Support medical device audits/inspections and lead activities related to corrective and preventative actions for any audit findings.
* Actively contribute to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
* Review and provide input to product DFMEAs.
* Assist local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable.
* Work cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.
* Assist in the preparation, review and submission of aggregate safety reports.
* Be accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division.
Requirements:
* A Master's degree in a related health science or equivalent skills, education, or experience.
* RAC certification is a plus.
* 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).
* Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
* Strong medical knowledge and understanding to support safety-related activities; background/experience with nutrition/nutritional products is a plus.
* Knowledge of Vigilance reporting regulations on a Global scale.
* Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
* Fluency in spoken/written English;
* Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
* Excellent communication and interpersonal skills, both written and spoken.
* Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects.
* Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
* High level of accountability and reliability.
* Demonstrate ability to work productively as a team.
* Ability to work in a fast-paced, changing environment.
* Ease of operating in high-stress, big decision situations.
* Continuous improvement mindset.
* Ability to influence a team in a positive way in relation to performance, change, and culture.
* Demonstrate broad knowledge of Abbott's business and how department processes/responsibilities interconnect.
* Mastery of the inventory deployment planning process.
* Exceptional problem-solving skills