Job title: Senior Regulatory Affairs Specialist – Premarket
Location: Parkmore, Galway. 1-2 days a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working
Company:
My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities.
Role:
As a Senior Regulatory Affairs Specialist you will will play a key role in supporting pre-market approval applications for their products across international markets. This is a fantastic opportunity, which will allow you to add real value to the future success of the company while working as part of a supportive, collaborative team in the new state-of-the-art facility in Galway. Work directly with R&D and Design Assurance throughout the full product lifecycle also work directly with regulatory authorities.
Responsibilities:
* Compile international regulatory submissions for Veryan products under development, as required.
* Adhere to regulatory submission timelines, identify risks and appropriate mitigations.
* Review data intended for submission in international regulatory applications, identify gaps and make recommendations.
* Participate in risk management activities for designated projects.
* Provide regulatory input during the design control process of development projects at every design phase.
* Review and contribute to regulatory aspects of change control, labelling changes etc. during premarket development projects.
* Review and contribute to clinical evaluation reporting activities, and participate on clinical operations projects e.g. clinical investigation protocols.
* Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the MDR 2017/745, and FDA Quality System Regulations 21 CFR Part 820 and ISO 14971.
* Work with project management on project planning activities.
* Identify opportunities for improvement within the RA department.
* Support Regulatory team members with training as required.
* Support Veryan Quality System activities as required.
Job title: Senior Regulatory Affairs Specialist – Premarket
Location: Parkmore, Galway. 1-2 days a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working
Company:
My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities.
Role:
As a Senior Regulatory Affairs Specialist you will will play a key role in supporting pre-market approval applications for their products across international markets. This is a fantastic opportunity, which will allow you to add real value to the future success of the company while working as part of a supportive, collaborative team in the new state-of-the-art facility in Galway. Work directly with R&D and Design Assurance throughout the full product lifecycle also work directly with regulatory authorities.
Responsibilities:
* Compile international regulatory submissions for Veryan products under development, as required.
* Adhere to regulatory submission timelines, identify risks and appropriate mitigations.
* Review data intended for submission in international regulatory applications, identify gaps and make recommendations.
* Participate in risk management activities for designated projects.
* Provide regulatory input during the design control process of development projects at every design phase.
* Review and contribute to regulatory aspects of change control, labelling changes etc. during premarket development projects.
* Review and contribute to clinical evaluation reporting activities, and participate on clinical operations projects e.g. clinical investigation protocols.
* Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the MDR 2017/745, and FDA Quality System Regulations 21 CFR Part 820 and ISO 14971.
* Work with project management on project planning activities.
* Identify opportunities for improvement within the RA department.
* Support Regulatory team members with training as required.
* Support Veryan Quality System activities as required.
Requirements:
* A degree level qualification in Engineering, Science, QA, or related field is essential.
* A minimum of five years experience at a senior regulatory level in the medical device industry is essential.
* A minimum of five years’ experience in the creation of regulatory submissions for premarket approval is required.
* Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
* Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.
* Excellent attention to detail and ability to produce reports at a high standard.
* Proven skills in the area of communication, organisation, computer literacy, problem solving and collaboration.
* Ability to work independently, with minimal supervision and use own initiative to respond to any issues arising.
Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie
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