Open positions

Regulatory Affairs Manager - Medical Devices 60-100%

Would you like to join and contribute to an award-winning, successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry?

SFL Group and its dynamic cross-functional team provide premium consulting support to globally active companies in the healthcare and life sciences fields. Our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

We have an opening for a Regulatory Affairs Manager Medical Devices.

Core responsibilities

  • Leading regulatory activities on assigned projects
  • Developing and leading regulatory strategy for devices, IVDRs, and combined products, with the main focus on EU and Swiss requirements
  • Ensuring regulatory compliance of assigned projects
  • Creating, reviewing, and updating technical files Interacting with Notified Bodies on behalf of clients
  • Interacting with client contact persons

Qualifications and requirements

  • Master/PhD in Pharmacy, Life Sciences or equivalent
  • 3+ years regulatory affairs experience in a device company or consultancy
  • Hands-on experience and in-depth understanding of the EU/Swiss regulatory processes; knowledge of FDA regulatory pathways is a strong plus
  • Analytical and systematic thinking, ability to synthesize information from various sources
  • Organization skills and attention to detail
  • Business orientation and flexibility
  • Ability to work independently and according to agreed timelines
  • Demonstrated personal accountability
  • A highly motivated and open minded personality, ability to work in an international environment
  • Excellent communication skills, particularly technical writing skills
  • Proficiency with Microsoft Office suite
  • Proficiency in English, additional languages welcomed
  • Swiss or EU/EFTA citizen or valid Swiss work permit

SFL offers

  • A stimulating role in an award winning company (Great Place To Work)
  • Continuous development and external educational trainings for each team member
  • Work in an energetic, motivated team
  • Rewards for outstanding accomplishments

About SFL

We provide innovative and customized services and solutions in the life science field from offices in Switzerland and the EU.

Our main areas of expertise are Regulatory Affairs, Medical Affairs, Quality Assurance & Supply Chain, Pharmacovigilance, Market Access, Public Affairs, and Legal & Compliance.

Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation.

We are a rewarding company with an excellent environment to grow.

Please send your application with CV, motivation letter and references via email to HR_SFL@sfl-services.com (no paper applications or phone calls).

Experienced Medical/Regulatory Writer 80-100%

Would you like to join and contribute to an award-winning, successful and growing multi-cultural organization in the heart of Europe and a world-leading region of the pharmaceutical industry?

SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

We have a position for an Experienced Medical/Regulatory Writer.

Core responsibilities

  • Preparation of documents and materials for a broad range of medical communication, regulatory and market access projects
  • Writing and reviewing of compelling, evidence-based texts supporting our clients’ communication objectives for documents such as CTDs, briefing books and manuscripts
  • Ensuring that created documents and materials are well-structured, with an appropriate flow of information and accurate in content and language
  • Project management ensuring compliance with agreed project objectives and timelines, and compliance with applicable regulations and guidelines
  • Providing ad-hoc support to other functions at SFL, as necessary

Qualifications and requirements

  • PhD in Life Sciences or related field
  • 3 years+ industry or consultancy experience as medical/regulatory writer or clinical scientist
  • Attention to detail
  • Excellent written and verbal communication skills in English (additional language welcome)
  • Structured and accurate working style
  • Strong interest in the pharmaceutical and medtech industry
  • Flexible and open-minded personality, with a keen interest to learn
  • Ability to work independently and efficiently on own responsibility
  • Swiss or EU/EFTA citizen or valid Swiss work permit

About SFL

We provide innovative and customized services and solutions in the life science field from offices in Switzerland and the EU. Our main areas of expertise are Regulatory Affairs, Medical Affairs, Quality Assurance & Supply Chain, Market Access, Public Affairs, Pharmacovigilance, and Legal & Compliance.

Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation. We are a rewarding company with an excellent environment to grow.

Please send your application (CV, motivation letter, references) to HR_SFL@sfl-services.com (no paper applications or phone calls).

Medical Writing Trainee 80-100%

Would you like to join and contribute to an award-winning, successful and growing multi-cultural organization in the heart of Europe and a world-leading region of the pharmaceutical industry?

SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

In our Basel office, we have an entry position for a Medical Writing Trainee.

Core responsibilities

  • Preparation of documents and materials for a broad range of medical communication, regulatory and market access projects
  • Writing of compelling, evidence-based texts supporting our clients’ communication objectives in the context of documents such as marketing authorization applications and manuscripts
  • Creating documents and materials that are well-structured with an appropriate flow of information and accurate in content and language
  • Working according to pre-defined project objectives and timelines, and in compliance with applicable regulations and guidelines
  • Providing ad-hoc support to other functions at SFL, as necessary

Qualifications and requirements

  • PhD in Life Sciences or related field
  • Attention to detail
  • Excellent written and verbal communication skills in English (additional language welcome)
  • Structured and accurate working style
  • Strong interest in the pharmaceutical and medtech industry
  • Flexible and open-minded personality, with a keen interest to learn
  • Ability to work independently and efficiently on own responsibility
  • Swiss or EU/EFTA citizen or valid Swiss work permit

About SFL

We provide innovative and customized services and solutions in the life science field from offices in Switzerland and the EU. Our main areas of expertise are Regulatory Affairs, Medical Affairs, Quality Assurance & Supply Chain, Market Access, Public Affairs, Pharmacovigilance, and Legal & Compliance.

Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation. We are a rewarding company with an excellent environment to grow.

Please send your application (CV, motivation letter, references) to HR_SFL@sfl-services.com (no paper applications or phone calls).

NOTICE TO SEARCH FIRMS/THIRD PARTY RECRUITMENT AGENCIES (RECRUITERS)

The Human Resources team manages the recruitment and employment process for SFL. Unsolicited resumes sent to SFL from recruiters do not constitute any type of relationship between the recruiter and SFL and do not obligate SFL to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring managers or employees.