Regulatory Affairs Specialist Systems & Software (M/F/D)

1-5 years

Not Disclosed

Remote Switzerland

10 Feb. 13, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Specialist Systems & Software (m/f/d)

Location: Rotkreuz, Zug, Switzerland
Category: Regulatory Affairs
Job ID: 202412-132978

Position Overview

At Roche, we are driven by our passion for innovation and our commitment to improving healthcare for all. We are seeking a Regulatory Affairs Specialist to join our team and contribute to the development of effective regulatory strategies for systems and software products in the healthcare field. This is an exciting opportunity for a dynamic and highly motivated individual with a proven track record in regulatory affairs.

As part of Roche’s team, you will collaborate with multiple functions, ensuring that regulatory approvals are obtained and maintained throughout the lifecycle of products. If you are passionate about making a global healthcare impact and thrive in an innovative environment, we want to hear from you.

Key Responsibilities

Regulatory Strategy & Submissions:
- Develop a deep understanding of regulatory frameworks such as IVDR and apply them to create and manage regulatory strategies for systems and software products.
- Coordinate the document compilation process for submissions and timely regulatory approvals, ensuring compliance throughout the product lifecycle.
Stakeholder Management:
- Build and maintain strong relationships with stakeholders, including both internal teams and external partners.
- Communicate effectively with stakeholders, ensuring alignment and managing expectations in order to drive successful regulatory outcomes.
Independent Decision-Making:
- Work independently with minimal direction, utilizing strong decision-making principles to identify issues, analyze solutions, and present clear recommendations.
- Identify improvement opportunities, troubleshoot issues, and implement cost-effective solutions while maintaining full compliance.
Innovation & Process Improvement:
- Drive innovation within the regulatory affairs process, bringing new ideas and seeking new opportunities to improve systems and processes.
- Embrace new technology and contribute to process efficiencies that align with the overall goals of the organization.
Team Collaboration & Knowledge Sharing:
- Collaborate with cross-functional teams, contributing as a team member and sharing knowledge to resolve conflicts and achieve team goals.
- Express ideas clearly, listen to colleagues, and recognize the contributions of others to foster a supportive, innovative work environment.

What You Bring

Educational Background:
- A degree in regulatory affairs, life sciences, engineering, or a related field.
- Additional certifications in regulatory affairs are a plus.
Experience:
- Proven experience in regulatory affairs, specifically in the systems and software domains in the healthcare sector.
- Familiarity with regulatory frameworks like IVDR and experience in managing regulatory submissions and approvals for moderate-complexity products.
Skills:
- Strong analytical and problem-solving abilities, with a proactive approach to overcoming challenges.
- Excellent stakeholder management and communication skills, including the ability to manage expectations and provide strategic counsel to cross-functional teams.
Personal Attributes:
- A self-starter who works independently with initiative, integrity, and a passion for compliance.
- A team player who shares knowledge, fosters collaboration, and continuously seeks improvements.
Mindset:
- Embraces an agile mindset, welcomes change, and encourages innovation.
- Acts with courage and passion, demonstrating a commitment to making a positive impact on global healthcare.

Why Roche?

At Roche, we believe that diversity, equity, and inclusion are key to success. We foster an environment where every individual is valued and empowered to contribute. Joining Roche means becoming part of a global team that is committed to innovating for better healthcare outcomes, collaborating across borders, and creating lasting impact.

If you are eager to take on a role that requires both technical expertise and a forward-thinking mindset in regulatory affairs, apply today and be part of a company that is shaping the future of healthcare.

How to Apply

Ready to make a difference? Apply today to join our team as a Regulatory Affairs Specialist and contribute to Roche’s mission of improving lives. We look forward to receiving your application!

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Regulatory Affairs Specialist Systems & Software (M/F/D)

Job Description

Job Title: Regulatory Affairs Specialist Systems & Software (m/f/d)

Position Overview

Key Responsibilities

What You Bring

Why Roche?

How to Apply

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