Principal Regulatory Affairs Specialist

Found in: beBee jobs IE - 2 weeks ago


Galway, Galway, Ireland Cpl Full time

My client, a leading medical device manufacturer, are seeking a Principal Regulatory Affairs Specialist for their Galway site. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart business.

Responsibilities

· Develop robust regulatory strategies

· Engage with regulatory agencies as the lead representative of the company

· Resolve questions from regulatory agencies for changes to existing products

· Lead regulatory filings to support submissions, license renewal and annual registrations.

· Support manufacturing strategy via a robust change control approach

· Mentor and coach more junior members of the department

· Keep abreast of regulatory procedures and changes.

· Develops internal procedures to ensure continuous regulatory compliance

· Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.

· Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.

Requirements

· Level 8 Science or Engineering Degree; Masters desirable

· Regulatory experience in Medical Devices and / or Pharmaceuticals is required.

· A Regulatory Affairs qualification is desirable.

If interested please send your CV to

#LI-EL2

#CplEmerLong


  • Lecturer in Regulatory Compliance and Quality

    Found in: beBee jobs IE - 2 weeks ago


    Galway, Galway, Ireland University of Galway Full time

    Applications are invited for an appointment as Lecturer in Regulatory Complianceand Quality at University of Galway. This is a part-time (0.5FTE), permanent post.The School of Biological and Chemical Sciences (SBCS) in the College of Science and Engineering at the University of Galway invites applications for a Lecturer in in Regulatory Complianceand Quality...

  • Training Specialist

    Found in: beBee jobs IE - 2 weeks ago


    Galway, Galway, Ireland TE Connectivity Full time

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewReporting to the Senior Quality Systems Engineer, the training Specialist in the Training Department, you will play a crucial role in ensuring the effectiveness and compliance of our training...

  • Training Specialist

    Found in: beBee jobs IE - 2 weeks ago


    Galway, Galway, Ireland TE Connectivity Full time

    Training SpecialistAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewReporting to the Senior Quality Systems Engineer , the training Specialist in the Training Department, you will play a crucial role in ensuring the effectiveness and...

  • Senior Design Assurance Manager

    Found in: beBee jobs IE - 2 weeks ago


    Galway, Galway, Ireland Cpl Full time

    My client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis. Responsibilities· Develop & manage execution of the Design Controls process.· Provide Design Assurance oversight within the NPI area.· Manage resources to support product launches.· Coordinate regular design reviews.· Ensure...

  • Associate MDR

    Found in: beBee jobs IE - 1 week ago


    Galway, Galway, Ireland Cpl Full time

    Associate MDR / Vigilance Specialist – 2 Year Contract My client, a leading medical device manufacturer, is seeking an Associate MDR / Vigilance Specialist for their Galway site. The Successful candidate will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life...

  • Principal Regulatory Affairs Specialist

    Found in: beBee S IE - 3 weeks ago


    County Galway, Ireland Cpl Full time

    My client, a leading medical device manufacturer, are seeking a Principal Regulatory Affairs Specialist for their Galway site. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart business. Responsibilities·        Develop robust regulatory...

  • Senior Regulatory Affairs Specialist

    Found in: Talent IE C2 - 7 days ago


    Galway, Ireland Medtronic Full time

    Senior Regulatory Affairs Specialist - Peripheral Vascular Health (hybrid) Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes...


  • Galway, Ireland Integer Holdings Corporation Full time

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers’ success Innovation We create better solutions Collaboration We create...

  • Principal Business Process Analyst

    Found in: Talent IE C2 - 3 days ago


    Galway, Ireland Boston Scientific Full time

      Job Title: Magellan Principal Business Process Analyst, Regulatory Product Controls Job Title:               Magellan Principal Business Process Analyst, Regulatory Product ControlsReporting to:        Snr Manager, Product Owner Regulatory Product Controls Closing Date:       13th May 2024 Apply through Success Factors attaching an...

  • Principal Business Process Analyst

    Found in: Talent IE C2 - 2 weeks ago


    Galway, Ireland Boston Scientific Full time

      Job Title: Magellan Principal Business Process Analyst, Regulatory Product Controls Job Title:               Magellan Principal Business Process Analyst, Regulatory Product ControlsClosing Date:       30th April 2024 More than the opportunity of a lifetime......the opportunity to improve lives  For more than 30 years, Boston Scientific...

  • Principal Business Process Analyst

    Found in: beBee S IE - 2 weeks ago


    Galway, Ireland Boston Scientific Full time

       Job Title: Magellan Principal Business Process Analyst, Regulatory Product Controls   Job Title:               Magellan Principal Business Process Analyst, Regulatory Product Controls Closing Date:       30th April 2024   More than the opportunity of a lifetime......the opportunity to improve lives    For more than 30 years,...

  • Principal Business Process Analyst

    Found in: Talent IE C2 - 3 weeks ago


    Galway, Ireland Boston Scientific Full time

    Job Title:  Magellan Principal Business Process Analyst, Regulatory Product Controls Job Title:  Magellan Principal Business Process Analyst, Regulatory Product Controls Closing Date: 21st April 2024 More than the opportunity of a lifetime......the opportunity to improve lives  For more than 30 years, Boston Scientific has advanced the...


  • Galway, Ireland Boston Scientific Full time

    Job Title:  Senior Business Process Analyst, Regulatory Product Control (Magellan Project) Closing Date: 28th March 2024 Work Mode: Hybrid More than the opportunity of a lifetime......the opportunity to improve lives  For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine. The Company's products help...


  • Galway, Ireland Boston Scientific Full time

       Job Title:              Senior Business Process Analyst, Regulatory Product Control (Magellan Project)Closing Date:       30th April 2024Work Mode:          Hybrid  More than the opportunity of a lifetime......the opportunity to improve lives  For more than 30 years, Boston Scientific has advanced the practice of less-invasive...

  • R&D Manager

    Found in: beBee S IE - 4 weeks ago


    Galway, Ireland Abbott Laboratories Full time

    About Abbott:Abbott is a global healthcare leader that helps people live more fully at all stages of life. For more than 125 years, we've brought new products and technologies to the world and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals...

  • Senior Scientist/Principal Scientist

    Found in: Talent IE C2 - 3 weeks ago


    Galway, Ireland Abbott Full time

    About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more...

  • Senior Scientist/Principal Scientist

    Found in: beBee S IE - 3 weeks ago


    Galway, Ireland Abbott Laboratories Full time

    About AbbottAbbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world:  in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more...

  • Senior Scientist/Principal Scientist

    Found in: beBee S IE - 3 weeks ago


    Galway, Ireland Abbott Laboratories Full time

    About AbbottAbbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world:  in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more...


  • Galway, Ireland Wallace Myers International Full time

    Quality Documentation Control Administrator Permanent Galway Position Title: Quality Documentation Control Administrator Position Summary The Quality Documentation Control Administrator is responsible for the managing and maintaining quality-related documents/quality records within the Quality Management System (QMS). The role of the documentation...


  • Galway, Ireland Wallace Myers International Full time

    Job Specification - Design Assurance Engineer Position Overview The Design Assurance Engineer will be instrumental in ensuring the quality, safety, and regulatory compliance of medical devices throughout the product development life-cycle. This role offers an exciting opportunity to contribute to groundbreaking advancements in healthcare within a...

  • Senior Design Assurance Manager

    Found in: Talent IE 2A C2 - 7 days ago


    Galway, Ireland Cpl Recruitment Full time

    My client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis. Responsibilities *Develop & manage execution of the Design Controls process. *Provide Design Assurance oversight within the NPI area. *Manage resources to support product launches. *Coordinate regular design reviews. *Ensure...

  • Quality Specialist

    3 weeks ago


    Galway, Ireland QA Resources Full time

    [fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4=""...


  • Galway, Ireland Cpl Healthcare Full time

    My client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis. Responsibilities · Develop & manage execution of the Design Controls process. · Provide Design Assurance oversight within the NPI area. · Manage resources to support product launches. · Coordinate regular design reviews. ·...


  • Galway, Ireland Wallace Myers International Full time

    Position Overview The successful candidate will play a key role in overseeing and optimizing the manufacturing processes for medical devices. This individual will collaborate closely with cross-functional teams to ensure the efficient production of high-quality products that meet regulatory standards and exceed customer expectations. Key Responsibilities ...

  • Helix Business Process Specialist

    Found in: Talent IE C2 - 1 week ago


    Galway, Ireland Abbott Full time

    About Abbott At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life....