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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

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Michael PageLausanne Region, CH

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P2620 - Safety Physician Oncology

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Robotics Engineer - SLAM & State Estimation

FlyabilityPaudex, VD, CH
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Quality Manager - MedTech

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Real Estate Agent (Relocation to Dubai)

BetterhomesLausanne, VD, CH
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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

Postdoctoral position in biology 100%

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The University of Lausanne Center of Integrative Genomics (CIG) is a vibrant, well-funded department with a focus on functional genomics and equipped with modern core facilities (see ).It is embedd... Voir plus

Manufacturing Engineer

Distalmotion SAÉpalinges, VD, CH
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The Manufacturing Engineer for surgical robotic instruments will play a key role across the full product lifecycle, from setting up new assembly lines to driving continuous improvement once product... Voir plus

Junior Quality Engineer - MedTech

Michael PageVaud, CH

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

Director, Business Development Neighborhood

VCLSLausanne, VD, CH
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VCLS supports biotech, pharma, and medtech companies from discovery to patient impact.Driven by a bold mission to accelerate life‑changing products to market, our global team of regulatory, clinica... Voir plus

Technical Consultant - Cardiac Rhythm management (m/f/d)

SWZ Medtronic (Schweiz) AGLausanne, Vaud, Switzerland

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Veilleurs Socio-Educatifs

AdeccoLausanne, Vd, Switzerland

Dans le cadre de futurs besoins prévus dès la fin de l'année,.Veilleurs socio-éducatifs (H/F).Vous souhaitez mettre vos compétences éducatives au service d'un public vulnérable et contribuer à leur... Voir plus

 • Nouvelle offre

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

CISO / Head of IT Security - Fulltime Hybrid

RetinAI MedicalLausanne, VD, CH
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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 20 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.