Hologic Senior Regulatory Compliance Specialist, EMEA in Belgium

Senior Regulatory Compliance Specialist, EMEA

Post Date 14 hours ago

As the Regulatory Compliance Specilaist you will ensure audit readiness by maintaining regulatory compliance to international standards, regulations and company procedures , overseeing the internal audit schedules, conducting internal audits and reporting on audit matrix to management. This role supports external audits and regional competent authorities during all the steps of identifying, reporting and finalizing audit nonconformance. Organizing and overseeing audit trainings for RAQA specialists and qualifying them as internal auditors through coaching. Leading internal audits of the QMS including interfacing with commercial and manufacturing sites. Assist manager with QMS integrations of newly acquired companies.

Your main duties and responsibilities will be to:

  • Responsible for collecting, interpreting and applying regulations to maintain an effective QMS

  • Ensure new regulations are communicated, understood and embedded in the Hologic EMEA region including dealers and distributors.

  • Taking the lead in conducting internal audits for the Commercial and Manufacturing sites.

  • Support supplier, distributor and corporate audits as required.

  • Engage in the external audit schedules and interact with notified bodies, regulatory agencies with regards to audits and responses until closure, as required.

  • Responsible for creating monthly reports and report to regional management on the status of internal and external audits, open actions, overdue activities and future audits.

  • Participates in the Management Review meetings, including collecting and collating data from different stakeholders, prepare and present slides.

  • Responsible for developing and maintaining a pool of qualified internal auditors, developing in-house skills and capabilities through internal and external training programs and personal coaching of QA/RA specialists.

  • Serves as a Regulatory Compliance Interface to other departments, partners and Regulatory Bodies. Instill a culture of compliance across the organization to ensure business growth.

  • Participate in global quality compliance projects and support implementation of harmonized procedures, as required.

  • Participate and support manager to implement Regulatory Strategies including QMS integrations of newly acquired companies

  • Responsible for writing, mapping, controlling and revising owned procedures.

  • Review and assess document changes affecting area of expertise in accordance with internal procedures

  • Perform other related duties as assigned

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We are looking for a candidate who has/can:

  • Bachelor or equivalent in a scientific discipline preferably biological sciences, life sciences or related discipline.

  • Experience in quality and/or compliance role within medical device or pharmaceutical industries.

  • Certification of Lead Auditor and or Certification of Internal Auditor

  • Has first experience interfacing with competent authorities regarding audit activities and resolution of observations.

  • Has good knowledge of applicable regulations and standards related to medical devices industry (ISO 13485, MDR/IVDR etc.)

  • Working knowledge of MS Word and Excel

  • Excellent writing skills

  • Excellent verbal communication skills

  • Ability to communicate effectively with a diverse team member and guest population

  • Ability to analyze and evaluate unusual situations and make sound judgments

  • Ability to analyze data, establish facts and draw valid conclusions

  • Ability to obtain, assemble, organize and evaluate information

  • Ability to present moderate to complex concepts in a clear and concise manner

  • Ability to provide coaching and guidance to staff

  • Ability to maintain focus and perspective on large scale goals and objectives

  • Ability to maintain professionalism and composure

  • Ability to maintain confidentiality

  • Ability to keep integrity and high ethics

  • Ability to accept constructive criticism

  • Team player

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to sit

• Regularly required to use a computer keyboard, mouse, and monitor

• Regularly required to talk and hear

• Occasionally required to walk to meeting locations

• Required to use close vision and adjust focus

Your work environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Work is performed primarily in an office environment

  • Travel expected up to 30%

Accountability:

  • Actions taken by employees in this position have financial impact on end results of the department and the company

Hologic offers a dynamic and innovative work environment along with excellent benefits that include bonus potential, stakeholder pension scheme, wellness program, life assurance and childcare vouchers.