Senior Manager Regulatory Affairs for Medical Devices and Person Responsible Wicklow

2 days ago

Dublin, Dublin City, Ireland Vectura Group plc Full time
Senior Manager Regulatory Affairs for Medical Devices and Person Responsible

Vectura Ireland Limited is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative. The successful candidate will also contribute to global regulatory strategy and drive the approval process for all medical device submissions, ensuring that Vectura's corporate goals are achieved.

Principal Accountabilities:

  1. As Person Responsible for Regulatory Compliance (PRRC):

    • Ensure full compliance with the Medical Device Regulations (MDR) in your capacity as PRRC for the European Authorized Representative.

    • Lead communications and interactions with Competent Authorities regarding Vectura's duties as Authorized Representative.
  2. In broader Regulatory Affairs responsibilities:

    • Contribute to global regulatory strategy and ensure the successful approval of medical devices worldwide.

    • Prepare final regulatory documentation and communicate with regulatory authorities and notified bodies.

    • Lead or support key projects, including EUDAMED implementation, Quality System Management Reviews (QSMR), UKCA, and development of new devices.

    • Ensure accurate maintenance and archiving of device registrations and technical documentation to meet legal and regulatory standards.

    • Support the creation of regulatory documentation, including risk management, design history files (DHF), instructions for use (IFU), and labeling.

    • Advise on regulatory strategy for clinical trials and commercial activities, including compliance with local legislation and language requirements.

    • Support the submission process for drug-device combination products in partnership with internal teams or external partners.

    • Analyze and interpret new or updated regulatory standards and assess their impact on Vectura's processes.

    • Contribute to the Vectura Regulatory Newsletter, providing updates on key regulatory topics.

    • Assist in planning, executing, and documenting verification and validation activities.

    • Serve as deputy to the Associate Director, EUAR & Importer, when needed.

This is an exciting opportunity for a senior professional with extensive experience in regulatory affairs for medical devices, eager to contribute to innovative healthcare solutions at Vectura.

Experience:

  1. Proven experience in regulatory affairs for medical devices.
  2. In-depth understanding of the Medical Device Directive and Medical Device Regulations.
  3. Strong communication and leadership skills, with the ability to collaborate across departments.
  4. 10 years' experience in Regulatory Affairs is a legal requirement to be an Authorized Representative.
  5. SME in MDR.

Apply now to join Vectura in shaping the future of medical device development

We're an international community of scientists, clinicians, engineers, regulatory specialists, quality managers and more. Working closely together in an open and inclusive way, we push ourselves and each other to develop innovative, world-leading drug delivery solutions that improve people's lives.

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