Medical Device Regulatory Strategist
7 days ago
**Responsibilities and Requirements:**
We are seeking a highly experienced Medical Device Regulatory Strategist to join our team at Vectura Group plc. As Senior Manager Regulatory Affairs for Medical Devices, you will play a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative. You will also contribute to global regulatory strategy and drive the approval process for all medical device submissions.
Key Responsibilities:
- Develop and implement effective regulatory strategies to ensure compliance with Medical Device Regulations (MDR).
- Lead communications and interactions with Competent Authorities and provide expert advice on regulatory matters.
- Collaborate with cross-functional teams to prepare final regulatory documentation and communicate with regulatory authorities and notified bodies.
- Manage and maintain accurate records of device registrations and technical documentation.
- Support the creation of regulatory documentation, including risk management, design history files (DHF), instructions for use (IFU), and labeling.
- Provide strategic guidance on regulatory matters, including clinical trials and commercial activities.
- 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.
This role requires a senior professional with extensive experience in regulatory affairs for medical devices, strong communication and leadership skills, and a deep understanding of the Medical Device Directive and Medical Device Regulations.
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Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full timeJob DescriptionVectura Group plc is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will 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.Principal Accountabilities:•...
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Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time**Job Description:**Vectura Group plc is seeking a highly experienced Senior Manager 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...
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Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full timeJob DescriptionWe are seeking a Senior Manager Regulatory Affairs who will 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.
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Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full timePrincipal AccountabilitiesAs 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.In broader Regulatory...
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