Regulatory Affairs Team Leader

vor 4 Wochen

Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit
Job Title: Team Leader Regulatory Affairs

Job Summary:

We are seeking a highly skilled Team Leader Regulatory Affairs to join our team at Straumann Group. As a key member of our regulatory affairs team, you will be responsible for ensuring that our products meet all applicable regulatory requirements and are safe and effective for their intended use.

Main Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with relevant regulations and standards.
  • Collaborate with cross-functional teams to ensure that products are designed, manufactured, and distributed in compliance with regulatory requirements.
  • Interact with regulatory authorities, notified bodies, and other approving authorities to ensure compliance and resolve any issues that may arise.
  • Guide and coach stakeholders on regulatory and compliance topics, with a focus on product safety and effectiveness.
  • Supervise and support the process of establishing project-related RA strategies and follow up on execution during the projects.
  • Create and maintain technical files and design dossiers to comply with relevant regulations.
  • Support the Regulatory Affairs teams in HQ and at subsidiaries/distributors in preparation of local submissions in line with agreed timelines and in compliance with relevant regulations.
  • Monitor and communicate new regulatory requirements and support in implementing these.

Requirements:

  • Technical or scientific graduate degree (FH/Uni/ETH).
  • Fluent (written and spoken) in English, strong command in technical writing.
  • Any additional language is an asset.
  • 10 years professional experience in Regulatory Affairs and/or Quality Management.
  • Proven record of Regulatory Management level positions at various medical device companies and/or types of devices (risk classes).
  • Detailed knowledge about the standards and norms for Medical Devices such as ISO 13485, EU 2017/745, FDA and Health Canada requirements.
  • Experience with other jurisdictions (APAC; LATAM and DEMEA) would be beneficial.
  • Experience with Biomaterials and class III products would be an asset.

Personal Attributes & Behaviors:

  • Pro-active and flexible individual with strong analytical skills, seeking to get things done and at the same time deal with a high variety of tasks.
  • Energetic, straight forward and performance-driven professional with strong execution abilities and customer focus.
  • Effective, convincing and professional communication, both verbally and in writing.
  • Capability to lead, guide and supervise a team as well as to cultivate a network of productive relationships in an international matrix environment.

Equal Opportunity Employer:

Straumann Group is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national origin, age, veteran status, or disability unrelated to job requirements.

Employment Type: Full Time

Alternative Locations: Switzerland: Basel

Travel Percentage: 0 - 20%

Requisition ID: 12069

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