Abbott Regulatory Affairs Project Manager in Zaventem, Belgium
Abbott is recruiting a Regulatory Affairs Project Manager .
As a Regulatory Affairs Project Manager , you lead project submissions for regulatory approvals and act independently to identify and resolve problems. You apply advanced regulatory expertise to guide cross-functional partners and you demonstrate strategic thinking and creativity in support of programs while acting as regional EMEA expert.
ROLES & RESPONSIBILITIES
Creates or reviews as applicable plans/protocols and reports, including Risk Management documentation, to support regulatory submissions.
Assesses proposed regulations and communicates new requirements to the organization.
Prepares robust regulatory applications and design dossiers per applicable EU regulations
Maintains CE-Mark certifications per Annex II sections 3 & 4 of Medical Device Directive 93/42/EC, including renewal applications and change reporting to Notified Bodies.
Creates, reviews and approves change requests.
Provides leadership and guidance (including training) to other members of the Regulatory / Quality staff.
Reviews device labeling or compliance with submissions and applicable EU regulations.
Provides Regulatory leadership to development teams:
Provides strategic input on Virtual Manufacturing / OBL activities (including all feasible alternatives and associated risks).
Drives cross functional alignment with issues that could have Regulatory / Quality implications on Virtual Manufacturing / OBL activities.
Independently interacts and builds partnerships with regulatory agencies.
Builds strategic partnerships to further departmental and organizational objectives.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations (Change Control).
Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Complies with EU and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Supports internal and external audits.
EDUCATION & COMPETENCIES
BA or BS degree (degree in a technical discipline highly preferred).
Profound regulatory affairs related expertise
7-10 years’ relevant experience with international regulations and submissions within regulatory function in medical devices industry
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to work independently with no oversight.
Ability to identify and solve problems in a strategic manner.
Ability to manage complex projects
Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.
In depth knowledge of ISO 13485, and the EU Medical Devices Directives (MDD and AIMDD). It also desirable to have knowledge of the new EU Medical Device Regulation
Good working knowledge of English
Knowledge of QMS requirements for manufacturing related activities (e.g. Good Manufacturing Practices, US FDA 21 CFR 820, Risk Management)
Willingness to travel up to 30%.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org