Senior RA Specialist – Structural Heart
Work with one the world’s largest medical device companies on their structural heart product lines, partly on new devices and mostly on existing devices with the availability to work remotely.
Key points are communication and attention to detail as this job focuses on existing and new products overseeing Post Market Surveillance. This team does end to end regulatory compliance and change control management. This role will mostly focus on change controls for global regulatory compliance and design changes from complaints and regulatory developments.
Responsibilities will include the following:
- Coordination of document packages for regulatory submissions and leading activities with regard to submissions, license renewal and annual registrations.
- Provide regulatory support for new products and therapies and changes to existing products.
- Work with stakeholders across several sites to develop robust regulatory strategies.
- Manage changes for labelling, manufacturing, marketing, and clinical protocols and evaluation reports for regulatory compliance.
- Develop company procedures to ensure compliance with all regulatory requirements and also ensuring stakeholders in various teams in the manufacturing process are aware of and understand relevant changes.
- Manage relationships with and deal directly with regulatory agencies.
- Support regulatory compliance and audits onsite.
- Identify and implement regulatory best practices.
Key Skills Required
- Level 7 degree in science, engineering, quality or regulatory affairs.
- Must have 4 years or more of relevant experience within Medical device or Pharma.
- Experience working directly with FDA, and notified bodies in the Europe and also Class III medical devices or DMS Drug master file is a must.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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