The Regulatory Affairs Associate will manage global regulatory submissions, ensure compliance with standards and regulations, and support annual reporting to notified bodies and authorities. This role requires expertise in medical device regulatory requirements, strong organisational skills, and the ability to thrive in a fast-paced, entrepreneurial environment.
Key Responsibilities:
* Manage global regulatory submissions, registrations, and compliance enhancements.
* Assist in implementing MDSAP and maintain QMS effectiveness.
* Support internal and external audits, including notified body audits.
* Collaborate with QA and suppliers to ensure validation and risk management compliance.
* Oversee Post Market Surveillance activities, including customer complaints, adverse event logging, and regulatory reporting.
* Monitor global regulatory trends, advising teams on compliance impacts.
* Prepare CE mark submissions, and 510(k) filings, and manage regulatory correspondence.
* Evaluate product, labelling, and promotional changes for compliance.
Required Skills & Experience:
* Bachelor’s degree in Engineering or Science with 4+ years in medical device regulatory affairs.
* Knowledge of ISO 13485, ISO 14971, EU MDR, US FDA regulations, and MDSAP.
* Proven experience managing projects and working with regulatory agencies.
* Strong problem-solving, communication, and organizational skills.
* Self-motivated team player who thrives in fast-paced environments.
This position offers a dynamic role in a collaborative and innovative environment with a competitive benefits package.
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