Nah, bagi Anda yang berminat bergabung di PT Alcon Batam, catat posisi dan syarat lowongan kerja berikut ini:

Regulatory Affairs Analyst

Job Description :

• Support device regulatory filings for US FDA, EU (MDD/MDR), and Canada regulatory requirements.
• Works in close collaboration with internal stakeholders and supports multiple projects.
• Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
• Support for responds to regulatory requests from across the organization in a timely manner.
• Partners with internal stakeholders (e.g., regions) to align on regulatory strategy in order to achieve business objectives.
• Support development of training programs for internal stakeholders, as needed.
• Support development of documents that are clear, concise, and complete to facilitate reviews/approvals.
• Perform Regular communication (quarterly) to key Global Regulatory Affair on projects Back up Single Point of Contact at site level for all regulatory communication and planning Attend bi-weekly meeting, monthly governance meeting and project specific meeting based on request Drive request for country registrations Drive, track and report on global registrations on monthly basis.
• Ensure relevant regulatory tracker is updated Maintain database and repository of license and registration document.

Skill & competencies :

• Have understanding of quality/regulatory affairs as it applies throughout the product lifecycle, preferably US FDA , EU MDD / MDR and Canada regulatory requirement.
• Knowledge on general manufacturing processes (i.e GMP).
• Problem solving skill.
• Communication skill on complex regulatory topics.
• Good report writing skill.

Educational Background :

• Minimum Bachelor degree in science major (e.g. pharmacy, chemistry, physics) or in engineering major (e.g. Industrial , Electrical, Machine).
• Other major would be considered as well.

Experiences :

• Minimum 1 years relevant experience in regulatory area or minimum 3 years in quality assurance / compliance function.

Berminat? Silakan klik link lowongan kerja terbaru Juni 2024 di PT Alcon Batam melalui link https://alcon.wd5.myworkdayjobs.com/en-US/careers_alcon?.***