Specialist,Regulatory Affairs Digitization

5-7 years

Not Disclosed

12 May 22, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Job

Company: ResMed

The primary role of the Regulatory Affairs function is to provide support and guidance regarding the regulatory environment throughout all stages of the life cycle of ResMed's products. This includes ensuring compliance, delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution. The role involves establishing systems and processes to comply with multiple regulatory frameworks to support the design, development, and manufacture of products that meet customer quality requirements. Collaboration with internal stakeholders and external regulators is essential to achieve business goals.

Responsibilities

Database Management: Support and maintain various internal and government databases relevant to ResMed's operations.
System Alignment: Define and communicate requirements for internal systems to ensure alignment with government database requirements.
Data Review: Conduct regular internal reviews of data to ensure accuracy, completeness, and compliance.
Cross-functional Collaboration: Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development and business processes.
Regulatory Intelligence: Stay up-to-date with changes in the regulatory environment and best practices.
Relationship Building: Build productive internal and external working relationships.
Project Leadership: Occasionally lead project teams and formally train junior staff.

Qualifications and Experience

Required:

Education: Bachelor’s degree in a related field such as life sciences, legal studies, or healthcare administration.
Experience: 5-7 years of experience in regulatory affairs, preferably within the healthcare or medical device industry.
Regulatory Knowledge: Strong understanding of enterprise systems, government databases, and regulatory requirements.
Skills:
- Excellent analytical and organizational skills.
- Ability to manage multiple projects simultaneously.
- Proficient in Microsoft Office Suite and database management.
- Strong communication skills, both written and verbal.
- Ability to effectively interact with all levels of management and government agencies.

Technical Skills:

RIMS: Proficiency in Regulatory Information Management Systems.
Data Warehousing: Experience with platforms such as Snowflake.
Database Systems: Familiarity with Oracle database systems.
Document Management: Knowledge of document management systems like Objective.

Preferred:

International Regulatory Affairs: Experience with international regulatory affairs.
Industry Knowledge: Familiarity with ResMed products and the respiratory care industry.

About ResMed

At ResMed (NYSE: RMD, ASX: RMD), we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD, and other chronic diseases. Our comprehensive out-of-hospital software platforms support professionals and caregivers, helping people stay healthy in their home or care setting of choice. By enabling better care, we improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems in more than 140 countries. To learn more, visit ResMed.com and follow @ResMed.

Why Join Us?

Joining ResMed means more than just making the world a healthier place. It’s about discovering a career that’s challenging, supportive, and inspiring. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace, and thriving on the innovative ideas this generates. We offer:

Profit Sharing: A proprietary and project-based formula for sharing company profit with each member, multiple times annually.
Premium Benefits: Medical, Dental, and Vision benefits through one of the nation’s largest networks, starting on your first day.
Promotion Index: A ‘What’s Next?’ approach for each member, empowering you to build your own journey.
Paid Time Off: Starting from day one of employment.

Equal Opportunity Employer

ResMed Corporation is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

(US/Canada only) ResMed is an equal opportunity/affirmative action employer. ResMed is an E-Verify Employer. ResMed is a smoke-free workplace.

We are a 2024 Circle Back Initiative Employer – we commit to responding to every applicant!

If this sounds like the workplace for you, apply now!

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Specialist,Regulatory Affairs Digitization

Job Description

About the Job

Responsibilities

Qualifications and Experience

Required:

Technical Skills:

Preferred:

About ResMed

Why Join Us?

Equal Opportunity Employer

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