Quality Systems Specialist, Regulatory Regulations
Boeing
Senior Regulatory Affairs Specialist
BD
full-time
Posted on:
Location Type: Hybrid
Location: San Jose • California • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Manage the regulatory process by interacting directly with country RA partners and government agencies;
- Provide updates on status of applications submitted to appropriate internal stakeholders;
- Coordinate meetings between relevant departments when necessary;
- Oversee submission package preparation including compilation of documentation required under applicable law or regulation;
- Review draft documents prepared by others prior to submission;
- Prepare correspondence regarding outcomes of submissions;
- Respond promptly to queries received during evaluation period;
- Liaise effectively between internal departments & external authorities throughout lifecycle of application until final decision has been made;
- Participate actively in negotiations where required;
- Contribute meaningfully towards resolution of any issues raised by authorities during evaluation phase;
- Collaborate closely with internal functions such as Marketing, Sales, Technical Support etc., to understand customer needs better;
- Identify potential areas where improvements could be made to enhance overall performance of existing products;
- Monitor changes in legislation relating to medical device industry;
- Conduct regular audits to ensure compliance with relevant regulations governing medical devices;
- Work collaboratively with internal stakeholders such as R&D, Quality Control, Manufacturing etc. to gather information pertaining to safety and effectiveness of products being developed.
Requirements
- Minimum 5 years’ experience working within regulatory affairs environment preferably focused on medical devices industry.
- Experience MUST be within a REGULATED Industry (examples; Medical Device, Aerospace, Automotive, Pharmaceutical)
- Strong analytical skills coupled with ability to think critically & solve problems independently.
- Excellent interpersonal skills with proven track record of building effective relationships internally & externally.
- Ability to communicate clearly & concisely both verbally & written form.
- Proven ability to manage multiple projects simultaneously while meeting tight deadlines.
- Proficiency in Microsoft Office Suite required (Word, Excel, PowerPoint).
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory process managementsubmission package preparationdocument reviewcompliance auditingproblem solvingproject managementanalytical skills
Soft skills
interpersonal skillscommunication skillscollaborationcritical thinkingrelationship buildingtime management
