
Regulatory Compliance Expert
1 day ago
This is a key role within our organization, responsible for ensuring that all regulatory activities are conducted in accordance with relevant laws and regulations.
We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers.
The successful candidate will be responsible for:
- Preparing, compiling, and submitting regulatory documents for Class III medical devices in accordance with global regulatory requirements.
- Maintaining regulatory approvals by preparing timely renewal applications, variations, and amendments.
- Supporting product development teams with regulatory input during the design and development phases.
- Conducting regulatory impact assessments for design or process changes.
Key responsibilities include coordinating with external regulatory agencies and notified bodies for regulatory submissions and audits.
Maintaining and updating regulatory files and records in compliance with company SOPs and applicable regulations is also an essential aspect of this role.
Assisting in internal audits and inspections, including document preparation and response coordination, is another critical responsibility.
Ensuring labelling, IFUs, and promotional materials comply with applicable regulatory requirements is also crucial.
This role involves participating in risk management, clinical evaluation, and post-market surveillance activities.
To succeed in this position, you will need to have a Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
A minimum of 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices, is required.
Knowledge of medical device regulations such as EU MDR, US FDA 21 CFR Part 820, ISO 13485, and CDSCO requirements is necessary.
Experience in dossier preparation (e.g., 510(k), PMA, CE technical files) is also highly desirable.
We offer a competitive compensation package and opportunities for professional growth and development.
If you are a motivated and detail-oriented individual with excellent communication skills, we encourage you to apply for this exciting opportunity.
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