Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie

Regulatory Affairs Specialist

Job ID: JOB-11490

Regulatory Affairs Specialist

Our client is a Limerick based Medical Device with a new opportunity for a Regulatory Affairs Specialist. As the Regulatory Affairs Specialist you will be working with a small on-site team and liaising with your colleagues around the world! In your role, you will act as the regulatory expert with involvement in new product development projects, sustaining engineering projects and MDR compliance program.

Responsibilities:

• Inputs to development of regulatory strategies and provides guidance and expertise.

• Communicates regulatory requirements to cross-functional groups in a concise and precise manner. MDD experience is welcomed; MDR preferred.

• Involved in labelling review

• Generate submission documentation and step files.

• Collaborate with other sister sites around the world.

• Prepares and presents gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner.

• Reviews and approves the project documentation for design reports, labelling, etc.

• Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.

• Working with regulatory submissions with exposure to programmable electrical equipment or R&D would be advantageous.

Requirements:

• Degree qualified in relevant Scientific discipline.

• 3+ years’ experience in a similar position.

• Knowledge of MDR or MDD and ISO:13485, ISO:14971 and IEC 60601standards

• Knowledge of FDA and international regulatory requirements is a plus.

For further information on this role please contact Marchon Monroe on 086 044 9473/ talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Marchon Monroe

JOB-11490

Regulatory Affairs Specialist

Marchon Monroe

Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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