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

  • Auditing Experience

  • Good working knowledge of English

  • IT knowledge

  • 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 corpjat@abbott.com