Regulatory Affairs Analyst
Regulatory Affairs Analyst
Posted on :
15-04-2025
Employer Active
1 Vacancy
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Job Description
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Summary
Varex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial xray products. The Regulatory Affairs Analysts is a key player in a crossfunctional team that includes Engineering Manufacturing Sales Marketing Quality and Customers. In addition the regulatory affairs analyst is expected to perform the following:Job Description
Roles and Responsibilities
- Keeps abreast of medical device regulatory procedures medical device safety standards and changes
- Strong working knowledge of FDA regulations guidance documents 93/42/ECC (MDD) EU 2017/745 (EU MDR) ISO14971 ISO13485 MDSAP and other global regulatory requirements and standards
- Compiles all materials required in submissions license renewal and annual registrations to FDA Health Canada China CFDA and others
- Helps drive applicable requirements of IEC 606011 and related medical device safety standards into design requirements
- Provides technical support regulatory guidance and oversight for Safety (UL) and EMC testing including EMC and Safety test plans working with test lab/test sites review and approve test reports
- Participates in postmarket surveillance GMP compliance 3rd party audits inspections reviews and approves advertising and promotions materials
- Recommends changes for labeling manufacturing marketing and usability protocols for medical device regulatory compliance
- Participates as team member to plan develop and implement regulatory strategy throughout the medical device product lifecycle
- Reviews and approves design outputs
- Uses regulatory information and knowledge to integrate regulatory perspectives into the organization its policies and procedures
- Reviews approves and recommends changes for labeling manufacturing marketing and test protocols for regulatory compliance and/or approval
- Adverse event determination and reporting to FDA EU and other countries
- Helps determine and facilitate Field Actions and Recalls
- Compiles Technical Files for Europe
- Participates in hosting/assisting with external audits from Notified Bodies customers and FDA
Minimum Requirements
- Bachelors Degreeinlife sciencesengineering regulatory compliance or:
- 5yearsof experienceinregulatorycomplianceinthemedical deviceindustryandmedical device safety standards
- 5 years of experience driving related medical device safety standards into design requirements
- 5 years of experience completing multiple submissions across health authorities
- Experience establishing or sustainingquality managementsystems
- Microsoft Office/ERP/QMS Software competency
Preferred Requirements
Masters Degreein life sciences engineering regulatory compliance; plus;
- 3 years of experience in regulatory compliance in the medical device industry and medical device safety standards
- 3 years of experience driving related medical device safety standards into design requirements
- 3 years of experience completing multiple submissions across health authorities
- Software experience in a regulated industry
Time Type:
Full timeJob Type:
RegularWork Shift:
N/APay Rate Type:
SalaryAll qualified applicants will receive consideration for employment without regard to race sex color religion sexual orientation gender identity national origin protected veteran status or on the basis of disability.
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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