Regulatory Affairs Specialist
hace 2 meses
Job Summary:
We are seeking a highly skilled Senior Regulatory Affairs Engineer to join our team at AbleCloset. As a key member of our Corporate Regulatory Affairs Team, you will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.
Key Responsibilities:
- Provide expert knowledge and guidance on regulatory legislation and guidelines for devices, particularly in UE, EEUU, and Canada territories.
- Prepare technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.
- Establish and maintain regulatory information systems, technical documentation files, and routine reports.
- Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
- Ensure regulatory compliance to global requirements and company policies.
- Support new product development activities.
- Review documents and product changes for regulatory submission impact.
- Provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.
- Review and approve product artworks and relevant marketing materials according to Sinclair strategies and any applicable regulatory requirements or standard.
- Identify, deliver, and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.
- Liaise with and assist vigilance team and risk management team with respect to requirements of product dossiers and relevant post-marketing activities as and where necessary.
- Assist and support inspections and audits.
- Liaise with, assist, and support in the creation of QMS process for regulatory aspects.
- Responsible for the local implementation and training of regulatory process.
- Responsible for leading and monitoring the assigned registration processes in the countries of commercialization of the Company's medical devices.
- Coordinate and prepare the documentation associated with the registers of medical devices to be delivered to the national or international Health Authorities.
- Administrative tasks and procedures in the different embassies and consulates for the legalization of the different documents necessary for the registration of the products in the different countries.
- Coordinate the signature of Quality and Release certificates of cosmetics and medical devices.
- Deputise for Manager as required.
Requirements:
- Minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device and with active medical devices (energy devices).
- Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC).
- Experience with the Medical Device Regulation.
- Knowledge of other regulatory legislation and guidelines, e.g., UE, EEUU, and Canada regulations.
- Excellent attention to detail when reviewing and preparing documentation.
- Organised, target-orientated, flexible, good time management skills.
- Strong written and oral communication skills.
- Fluency in written and spoken English.
- Ideally, if you also have experience with cybersecurity or AI.
What We Offer:
- Competitive fixed salary aligned with the market + variable.
- Medical + Dental Insurance.
- Hybrid work model.
- Flexible schedule + short Friday.
- Fruit at the office.
- Enjoyable, dynamic, and international environment.
About Us:
AbleCloset is a company that values development and autonomy. We encourage flexibility, accountability, and collaboration. Our people thrive on engagement, development, and a varied workload.
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