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Secrétariat médical Offres d'emploi - Pully, VD

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Secrétariat médical • pully vd

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Regulatory affair manager

Approach People RecruitmentLausanne, Switzerland

As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, ... Voir plus

Interim Legal Counsel Medtech - Lausanne (80-100%)

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Physiothérapeute avec reconnaissance CRS

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We anticipate the application window for this opening will close on - 11 Jul 2026.Careers that change lives start here.Medtronic is a global leader in healthcare technology with a Mission to allevi... Voir plus

Quality Technician II.

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P2620 - Safety Physician Oncology

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Quick Apply

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Direktionssekretärin

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Nach drei Jahren, in denen das Unternehmen ausschließlich von seinen Gründern geführt wurde, tritt Medigo nun in eine Phase des strukturierten Wachstums ein.Wir suchen unsere ersten beiden Mitarbei... Voir plus

 • Offre sponsorisée

Quality Manager - MedTech

Michael PageLausanne Region, CH

Lead Quality Operations activities across internal manufacturing and external partners.Ensure compliance with ISO 13485, FDA requirements, and applicable quality regulations.Manage and develop a te... Voir plus

Real Estate Agent (Relocation to Dubai)

BetterhomesLausanne, VD, CH
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Join the Betterhomes Family: Where Innovation Meets Heart!.Location - Relocation to Dubai!!!.At Betterhomes, we don't just help people find homes—we've been making dreams come true for over 38 year... Voir plus

Regulatory affair Manager – Medical devices

Approach People RecruitmentLausanne, Switzerland

As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, ... Voir plus

Quality Technician

Michael PageLausanne Region, CH

Collaborate with contract manufacturers and suppliers to ensure quality requirements are met throughout the product lifecycle.Review and approve manufacturing batch records to ensure compliance wit... Voir plus

Purchasing Specialist

FlyabilityPaudex, VD, CH
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Review and approve manufacturing batch records while ensuring adherence to quality and regulatory requirements.Support incoming inspection activities, including review of certificates, inspection r... Voir plus

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Regulatory affair Manager - Medical devices

Approach People RecruitmentLausanne, State, Switzerland

Job Description: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical,... Voir plus

Global Medical Affairs Lead - Diabetes & Obesity

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Global Medical Affairs Lead - Diabetes & Obesity.Contract type / duration: Permanent.Start date: As soon as possible.Deadline for applications: 12 / 07 /2026.Be a force for good and accelerate chan... Voir plus

CISO / Head of IT Security - Fulltime Hybrid

RetinAI MedicalLausanne, VD, CH
Quick Apply

Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland.Our mission is to enable the right decisions sooner in healthcare, through... Voir plus

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Regulatory affair manager

Regulatory affair manager

Approach People RecruitmentLausanne, Switzerland
Il y a 17 jours
Description de poste

Job Description

: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards.

Responsibilities:

  • Develop and implement regulatory strategies for product development, registration, and commercialization.
  • Prepare and submit regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), 510(k), Pre-Market Approval (PMA), or other regulatory filings, as required.
  • Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing, to ensure compliance with regulatory requirements throughout the product lifecycle.
  • Monitor and interpret changes in regulations and guidelines and communicate potential impact to relevant stakeholders.
  • Manage regulatory documentation and maintain regulatory compliance records.
  • Participate in regulatory audits and inspections as needed.
  • Represent the company in regulatory interactions and meetings with regulatory agencies.

Qualifications:

  • Bachelor's degree in a scientific or healthcare-related field; advanced degree Master's or PhD) preferred.
  • Minimum of [X] years of experience in regulatory affairs within the pharmaceutical, medical device, or healthcare industry.
  • Strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR), ICH guidelines, and other applicable regulations.
  • Experience with regulatory submissions, including INDs, NDAs, 510(k)s, PMAs, or other regulatory filings.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
  • Regulatory Affairs Certification (RAC) preferred.