Job Details: Regulatory Affairs Specialist- EBDFull details of the job.
Vacancy Name
Vacancy Name Regulatory Affairs Specialist- EBD
Vacancy No
Vacancy No VN309
Employment Type
Employment Type Full-Time
Location
About the Job
Sinclair is looking for a Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBD). In this role, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide. You will collaborate with cross-functional teams to maintain and submit regulatory approvals, driving the successful launch of products in global markets. This is an exciting opportunity to contribute to the efficiency and effectiveness of regulatory processes while ensuring alignment with global standards and business objectives.
About Sinclair Founded in 1971, Sinclair is a global medical aesthetics organisation, 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.
This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.
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 IntegrityStay ahead of the gameOne team, one goal Description Description Essential:
-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.
Role 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.
General Competencies:
-Strong analytical and deductive reasoning skills.
-Attention to detail.
-Excellent communication skills.
-Goal-oriented with a rigorous yet flexible approach.
-Adaptable and open-minded.
-High integrity and adherence to professional ethics.
-Ability to cooperate effectively across functions and teams.
If this sounds like you and you meet the requirements, please apply, we would love to hear from you.
Please note if we receive a high volume of applications, we may close the role before the closing date noted.
By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad.
If you have any questions, please email ****** .
Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.
Key Responsibilities
Key Responsibilities Roles and Responsibilities:
-Prepare, submit, and manage regulatory applications for Energy-Based Device (EBD) product registrations, amendments, renewals, and post-approval changes in assigned countries based on company priorities.
-Coordinate with cross-functional departments to gather and compile necessary documentation for product registrations, ensuring compliance with country-specific regulatory requirements.
-Monitor and interpret international regulatory requirements for EBD product registrations, providing strategic advice and assessing operational impacts.
-Advise on jurisdiction-specific regulatory requirements, ensuring that these are communicated and incorporated into the design inputs and development processes of new and existing products.
-Collaborate in the development and revision of Standard Operating Procedures (SOPs) related to regulatory processes, contributing to the continuous improvement of the company's regulatory compliance framework.
-Maintain up-to-date records of registration statuses, submissions, and communications with regulatory authorities and involved stakeholders, including distributors and importers.
-Perform administrative tasks such as processing document legalization at embassies and consulates to support the registration of products in different countries.
-Perform other regulatory affairs duties as assigned.
Benefits 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.
We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.
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