Regulatory Affairs Engineer- On-Site- Scottsdale, AZ

Scottsdale, AZ - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.

Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product;
Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies;
Acts as the liaison between Innovative Health the FDA and other international regulatory bodies;
Reviews complaints/adverse events for submission of MDRs;
Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors legibility and missing information;
Participate in project development teams and review plans reports risk management risk assessments and design reviews associated with product and process projects;
Provide regulatory assessments for manufacturing line extensions design changes and validation activities;
Participates in internal/external audits and prepares responses to support audit findings or other respective actions related to such audits;
Conduct regulatory review and approval of change orders CAPA/nonconformance and related project documentation;
Review labeling and promotional material to ensure compliance with applicable regulations;
Implement and maintain unique identifier (UDI) activities for implementation /compliance;
Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards;
Assists with DFMEA and PFMEA risk assessments;
Maintain and disseminate current knowledge base of existing regulations standards or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
Develops and implements company policies and procedures;
Assists in archiving regulatory documentation and maintaining related databases.

Qualifications:

Minimum of Bachelors degree in technical field (i.e. Bioengineering Electrical Engineering Mechanical Engineering or other technical field);
Expert level knowledge of FDA 21 CFR Part 820 and 510K submission requirements;
Experience and knowledge of Canadian Medical Device Regulations MDD MDSAP and ISO standards preferred;
Minimum of five years medical device regulatory experience;
Working knowledge of QMS systems and functionality;
Previous 510(k) submissions;
Ability to work in a fast paced collaborative team environment;
Ability to handle multiple projects and coordinate cross functional teams;
Ability to communicate effectively with management direct reports and external vendors;
Ability to write technical documents (procedures test methods protocols and reports);
Ability to recommend technical solutions;
Ability to specify regulatory requirements for products;
Ability to work with little supervision;
Ability to use personal computers including software such as: Word PowerPoint Excel Project and Minitab;
Self-starter and highly motivated;
Sterilization experience is a plus.

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially dist...

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.

Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product;
Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies;
Acts as the liaison between Innovative Health the FDA and other international regulatory bodies;
Reviews complaints/adverse events for submission of MDRs;
Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors legibility and missing information;
Participate in project development teams and review plans reports risk management risk assessments and design reviews associated with product and process projects;
Provide regulatory assessments for manufacturing line extensions design changes and validation activities;
Participates in internal/external audits and prepares responses to support audit findings or other respective actions related to such audits;
Conduct regulatory review and approval of change orders CAPA/nonconformance and related project documentation;
Review labeling and promotional material to ensure compliance with applicable regulations;
Implement and maintain unique identifier (UDI) activities for implementation /compliance;
Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards;
Assists with DFMEA and PFMEA risk assessments;
Maintain and disseminate current knowledge base of existing regulations standards or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
Develops and implements company policies and procedures;
Assists in archiving regulatory documentation and maintaining related databases.

Qualifications:

Minimum of Bachelors degree in technical field (i.e. Bioengineering Electrical Engineering Mechanical Engineering or other technical field);
Expert level knowledge of FDA 21 CFR Part 820 and 510K submission requirements;
Experience and knowledge of Canadian Medical Device Regulations MDD MDSAP and ISO standards preferred;
Minimum of five years medical device regulatory experience;
Working knowledge of QMS systems and functionality;
Previous 510(k) submissions;
Ability to work in a fast paced collaborative team environment;
Ability to handle multiple projects and coordinate cross functional teams;
Ability to communicate effectively with management direct reports and external vendors;
Ability to write technical documents (procedures test methods protocols and reports);
Ability to recommend technical solutions;
Ability to specify regulatory requirements for products;
Ability to work with little supervision;
Ability to use personal computers including software such as: Word PowerPoint Excel Project and Minitab;
Self-starter and highly motivated;
Sterilization experience is a plus.

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

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About Company

Innovative Health

HEALTHCARE NEEDS NEW ANSWERS Hospitals in the US are financially fragile and the pandemic has brought many to the verge of bankruptcy. Meanwhile, advancements in pharmaceuticals and medical technology carry the promise of better patient care – and a hefty price tag that threatens the ... View more

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