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Regulatory Affairs Specialist

hace 1 mes

Barcelona, Barcelona, España The Zonal Group A tiempo completo
Job Details:

Regulatory Affairs Specialist

  • EBD

Vacancy Name: Regulatory Affairs Specialist

Vacancy No: VN309

Employment Type: Full-Time

Location: About the Job

Sinclair is seeking a Regulatory Affairs Specialist to manage 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 Integrity

Stay ahead of the game

One team, one goal

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