Regulatory Affairs Analyst
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Job Location:
Calamba - Philippines
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
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Summary
Varex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering Manufacturing Sales Marketing Quality and addition the regulatory affairs analyst is expected to perform the following:Job Description
Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering Manufacturing Sales Marketing Quality and addition the regulatory affairs analyst is expected to perform the following:
- Keeps abreast of medical device regulatory procedures medical device safety standards and changes in global regulations.
- Strong working knowledge of FDA regulations UK EU ISO13485 Brazil Australia China Japan Canada and Rest of World
- Compiles all materials required in submissions license renewal and annual registrations to FDA Health Canada China NMPA and other international authorities.
- Supports global product registrations including the compilation and maintenance of regulatory dossiers technical documentation and country-specific submission materials.
- Performs device classification assessments in accordance with regulatory frameworks in the U.S. Canada EU China and other global markets
- Maintains strong understanding of country-specific documentation and regulatory expectations for product submissions compliance and import/export.
- Prepares and provides Certificates of Compliance Declarations of Conformity and other supporting compliance documents for internal and external stakeholders.
- Participates in post-market 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.
- Participate 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.
- Compiles and maintains technical files for medical device products
- Participates in hosting/assisting with external audits from Notified Bodies and Product Safety Agencies
Required Skills and Experiences
- Bachelors Degree in life sciences engineering regulatory compliance
- 2 years of experience in regulatory compliance in the medical device industry and medical device safety standards.
- 2 years of experience driving related medical device safety standards into design requirements.
- 2 years of experience completing multiple submissions across health authorities.
- Experience with Class I II and/or III medical devices and industrial products (including experience determining device classifications globally).
- Proven track record of preparing and managing regulatory submissions (e.g. FDA 510(k) Health Canada License Applications EU Technical Files NMPA dossiers etc.).
- Experience supporting product registrations and certifications across multiple international markets.
- Microsoft Office/ERP/QMS Software competency
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
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Varex Imaging Corporation is the world’s largest independent supplier and manufacturer of X-ray imaging components and image processing solutions.
