Regulatory Affairs Specialist
hace 1 mes
Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBD).
Key Responsibilities:
* Ensure compliance with international regulatory authorities
* Support market entry for EBDs worldwide
* Collaborate with cross-functional teams to maintain and submit regulatory approvals
* Drive the successful launch of products in global markets
About the Company: Sinclair is a global medical aesthetics organization that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
Requirements:
* Bachelor's degree in Life Sciences or related field, or equivalent work experience in regulatory affairs with a focus on medical device product registrations
* 3+ years of experience in Regulatory Affairs within the Medical Devices industry
* Proficiency in computer skills, including but not limited to Windows and MS Office
* Full proficiency in English is required
Competencies:
* Expertise in regulatory pathways and documentation requirements for device registrations
* Ability to manage complex projects and deliverables within specified timelines
* Self-motivated and able to work autonomously and proactively
* Strong attention to detail with a methodical approach to documentation and data management
* Collaborative team player with the ability to work in a multidisciplinary environment
* Demonstrates personal responsibility and confidence, with excellent written and verbal communication skills
* Assertive, decisive, and able to positively influence others across the company
* Strong time and priority management; excellent planning and organizational skills
* Promotes a culture of accuracy and quality throughout the business
* Flexible and adaptable, with a team-oriented mindset
Our Vision: Providing aesthetic excellence globally
Our Mission: Driving the advancement of product quality and customer satisfaction, investing in innovation and people
Our Values: Act with Integrity, Stay ahead of the game, One team, one goal
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