Direct message the job poster from Guided Solutions
International Candidate Manager │Medical Devices
An innovative medical device company dedicated to developing implantable technologies for chronic conditions is looking for an Associate Manager – Regulatory Affairs to join its expanding Regulatory & Quality team.
In this role, you’ll ensure that products comply with EU medical device regulations and global quality standards, while also acting as the Person Responsible for Regulatory Compliance (PRRC). This is a key position supporting product compliance, documentation, post-market surveillance, and quality system activities throughout the product lifecycle.
Key responsibilities:
1. Oversee EU product release and regulatory documentation.
2. Support technical file generation and regulatory change assessments.
3. Lead post-market compliance and incident reporting.
4. Maintain alignment with ISO 13485 and EU MDR standards.
5. Act as the contact point for regulatory bodies and notified organisations.
To be considered for the role, you must closely match the following criteria:
1. Degree in life sciences, engineering, or a similar field.
2. Strong foundation in EU MDR and ISO 13485.
3. 3–5 years’ experience in a regulated environment, including at least 1 year in Regulatory Affairs or Quality Systems.
4. Excellent attention to detail and communication skills.
5. Located in Dublin or 2h drive from Dublin.
You’ll be part of a mission-driven team focused on innovation, integrity, and patient impact. This is a great opportunity for someone ready to grow their career in an international, high-impact environment. Remote flexibility and travel (up to 30%) may be expected.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Product Management
Industries
Hospitals and Health Care, Biotechnology Research, and Medical Equipment Manufacturing
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