Regulatory Affairs Specialist
3 weeks ago
Vectura Group plc is seeking a highly skilled Regulatory Affairs Specialist to lead our medical device regulatory activities. This role involves assuming the role of Regulatory Affairs Manager with specialized expertise in medical devices and drug-device combination products (DDCPs).
About Vectura Group plc
We are a global leader in developing innovative inhaled therapies and drug-device combination products (DDCPs). Our team is dedicated to achieving excellence in patient care through cutting-edge medical technology.
Responsibilities
This position requires strong leadership skills to drive the success of our medical device and DDCP regulatory activities. Key responsibilities include:
- Regulatory Leadership: Assume the role of Regulatory Affairs Manager with specialized expertise in medical devices and DDCPs.
- Submission & Compliance: Contribute to the regulatory strategy and execution of global regulatory submissions in accordance with the Medical Device Directive (MDD) and Medical Device Regulations (MDR).
- Cross-Functional Collaboration: Collaborate effectively with teams in regulatory, quality assurance, and device engineering to ensure seamless regulatory support and compliance throughout product development and commercialization.
Qualifications & Experience
To be successful in this role, you will need:
- Proven experience in Regulatory Affairs, particularly in medical devices and drug-device combination products (DDCPs).
- In-depth knowledge of MDD, MDR, ISO standards, FDA regulations, and other relevant global regulatory frameworks.
- Experience authoring MDR Technical Files, Design Dossiers, and other regulatory submissions.
Salary
The estimated salary for this role is $120,000 - $180,000 per year, depending on location and experience.
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