Medical Device Regulatory Affairs Specialist
hace 15 horas
Company Overview:
Sinclair, a global medical aesthetics organisation, 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.
About Sinclair:
Founded in 1971, we are committed to providing aesthetic excellence globally through the advancement of product quality and customer satisfaction, investing in innovation and people.
Job Description:
We are seeking a highly motivated Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBD). As a key member of our team, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide.
Key Responsibilities:
- Collaborate with cross-functional teams to maintain and submit regulatory approvals
- Ensure alignment with global standards and business objectives
- Drive the successful launch of products in global markets
- Contribute to the efficiency and effectiveness of regulatory processes
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 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
- Excellent written and verbal communication skills
Salary:
$85,000 - $110,000 per annum, depending on experience
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