Regulatory Affairs Specialist
hace 14 horas
Sinclair, a global medical aesthetics organisation, is seeking an experienced Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBDs). This role will involve ensuring compliance with international regulatory authorities and supporting market entry for EBDs worldwide.
About the JobThis is an exciting opportunity to contribute to the efficiency and effectiveness of regulatory processes while ensuring alignment with global standards and business objectives. As a Regulatory Affairs Specialist, you will collaborate with cross-functional teams to maintain and submit regulatory approvals, driving the successful launch of products in global markets.
Key Responsibilities- Maintain knowledge of international regulatory requirements and ensure compliance with relevant regulations
- Collaborate with cross-functional teams to develop and implement regulatory strategies
- Manage and submit regulatory approvals, including device registrations and labeling submissions
- Support market entry for EBDs worldwide, including conducting market research and developing business cases
- Develop and maintain relationships with regulatory agencies and industry partners
- Bachelor's degree in Life Sciences or related field, or equivalent work experience in regulatory affairs
- 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
Sinclair was founded in 1971 and delivers an extensive product range through its in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets. With a presence in 55 countries worldwide, Sinclair continues to expand its product range and enter new markets and territories.
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
The estimated salary for this role is around $80,000-$120,000 per year, depending on location and experience. If you are a motivated and experienced Regulatory Affairs Specialist looking to take your career to the next level, please apply today.
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