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Loblaw Companies Limited Jobs overseas

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Regulatory Affairs Specialist at Piper Companies
Pennsylvania, Pennsylvania, USA - Full Time
Skills Needed
Powerpoint, Teams, Regulatory Affairs, Management Skills, Regulatory Submissions, Medical Devices, Promotional Literature, Excel, Microsoft Office
Specialization
Health or science-related field engineering degree is a plus
Qualification
Graduate
Experience Required
Minimum 2 year(s)
ASIC Packet Processing Architect at Piper Companies
Saratoga, California, USA - Full Time
Skills Needed
Microarchitecture, Serdes, Networking Solutions, High Speed Interfaces, Design
Qualification
Graduate
Experience Required
Minimum 15 year(s)
Manufacturing Associate II (Downstream) at Piper Companies
Gaithersburg, Maryland, USA - Full Time
Skills Needed
Aseptic Processing, Chromatography, Aseptic Technique, Tff
Qualification
BSc
Resident Engineer - Networking at Piper Companies
Washington, District of Columbia, USA - Full Time
Skills Needed
Network Design, Presentation Skills, Scripting Languages, Jncip, Ccnp, Python, Rsvp, Operations, Routing Protocols, Design, Ccie
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Lead Product Manager (Credit Cards) at Piper Companies
McLean, VA 22102, USA - Full Time
Skills Needed
Communication Skills, Product Strategy, Credit Cards, Finance, Product Management, P&L Management, Digital Channels, Consumer Lending
Qualification
MBA
XSOAR Consultant at Piper Companies
Remote, Oregon, USA - Full Time
Skills Needed
Security Analysis, Performance Metrics, English, Parsing, Regular Expressions, Presentation Skills, Splunk
Specialization
Relevant Field
Qualification
Graduate
Experience Required
Minimum 4 year(s)
ERP Technical Specialist at Piper Companies
Raleigh, North Carolina, USA - Full Time
Skills Needed
Business Rules, Sql
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Wireless Engineer (30% Travel) at Piper Companies
New York, New York, USA - Full Time
Skills Needed
Enterprise Networking, Traffic Engineering
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Senior Systems Administrator at Piper Companies
Annapolis Junction, Maryland, USA - Full Time
Skills Needed
Security+, Rmf, Operating Systems, Directory Services, Active Directory
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Quality Assurance Specialist at Piper Companies
West Point, Pennsylvania, USA - Full Time
Skills Needed
Communication Skills
Specialization
Engineering science or related field
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Lead Product Manager - Credit Cards at Piper Companies
McLean, VA 22102, USA - Full Time
Skills Needed
Analytical Skills, Product Management, Finance, Consumer Lending, Product Innovation, Credit Cards, Strategy
Specialization
Business, Finance, Marketing
Qualification
MBA
TechOps Administrator at Piper Companies
Redmond, Washington, USA - Full Time
Skills Needed
Polygraph, Communication Skills, Active Ts/Sci Clearance
Specialization
Assist with user account provisioning certificate issuance and troubleshooting
Qualification
Trade Certificate
Experience Required
Minimum 1 year(s)
UC Administrator at Piper Companies
Miami, Florida, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
IT Specialist Senior at Piper Companies
Annapolis Junction, MD 20701, USA - Full Time
Skills Needed
Linux, Customer Service, Communication Skills, Contract Requirements, Deliverables, Conflict Resolution
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Contracts Support Specialist at Piper Companies
Colorado Springs, Colorado, USA - Full Time
Skills Needed
Active Ts/Sci Clearance, Jcids, Procurement, Budgeting
Specialization
Federal contracting and procurement
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Business Development Manager at Piper Companies
Remote, Oregon, USA - Full Time
Skills Needed
Radar, Launch Vehicles, Software, Communication Skills, Space Systems
Qualification
Graduate
MQ Administrator at Piper Companies
Annapolis Junction, Maryland, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
A mq administrator role
Qualification
Graduate
Experience Required
Minimum 7 year(s)
VMWare Administrator at Piper Companies
Quantico, VA 22134, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 4 year(s)
Packet Processor Architect at Piper Companies
Saratoga, California, USA - Full Time
Skills Needed
Architecture Modeling, Performance Tuning
Qualification
Graduate
Experience Required
Minimum 15 year(s)
MQ Administrator at Piper Companies
Annapolis Junction, Maryland, USA - Full Time
Skills Needed
Websphere, Dual Citizenship
Qualification
Graduate
Experience Required
Minimum 7 year(s)
Regulatory Affairs Specialist at Piper Companies
Pennsylvania, Pennsylvania, USA -
Full Time

Start Date

Immediate

Expiry Date

04 Dec, 25

Salary

90000.0

Posted On

05 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Powerpoint, Teams, Regulatory Affairs, Management Skills, Regulatory Submissions, Medical Devices, Promotional Literature, Excel, Microsoft Office

Industry

Pharmaceuticals

Description

Piper Companies is seeking a Regulatory Affairs Specialist to join an orthopedic medical device company headquarters in Audubon, Pennsylvania. The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for 510(k) submissions, as well as approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.

Responsibilities of the Regulatory Affairs Specialist include:

  • Partner with Product Development and management to prepare and review 510(k)submissions, as well as preparing final 510(k) submissions and obtaining required management approval
  • Assist in the completion of IDE and PMA submissions for IDE clinical trials, help prepare PMA packages, including non-clinical manufacturing, and clinical sections, as well as obtain and review clinical study data, as needed for IDE and PMA reporting and routine maintenance of approved PMAs coordination and preparation
  • Review Document Change Orders for Regulatory Compliance, including drawings and labeling changes
  • Determine Regulatory Pathway for new/changed products under departmental guidelines and train new staff on relevant Regulatory process
  • Review and approve Note-to-File documentation for minor changes to 510(k) cleared products or systems and understand company’s products
  • Develop relevant Regulatory SOPs when necessary

QUALIFICATIONS FOR THE REGULATORY AFFAIRS SPECIALIST INCLUDE:

  • Minimum of 2-5 years’ experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical devices
  • Bachelor’s degree in health or science-related field, Engineering degree is a plus
  • Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
  • Experience assessing regulatory impact of product/process changes, experience reviewing labeling, promotional literature, etc.
  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
  • Excellent communication, listening, time management skills, as well as demonstrating ability to work on multiple projects at once
Responsibilities
  • Partner with Product Development and management to prepare and review 510(k)submissions, as well as preparing final 510(k) submissions and obtaining required management approval
  • Assist in the completion of IDE and PMA submissions for IDE clinical trials, help prepare PMA packages, including non-clinical manufacturing, and clinical sections, as well as obtain and review clinical study data, as needed for IDE and PMA reporting and routine maintenance of approved PMAs coordination and preparation
  • Review Document Change Orders for Regulatory Compliance, including drawings and labeling changes
  • Determine Regulatory Pathway for new/changed products under departmental guidelines and train new staff on relevant Regulatory process
  • Review and approve Note-to-File documentation for minor changes to 510(k) cleared products or systems and understand company’s products
  • Develop relevant Regulatory SOPs when necessar
Regulatory Affairs Specialist at Piper Companies
Pennsylvania, Pennsylvania, USA - Full Time
Skills Needed
Powerpoint, Teams, Regulatory Affairs, Management Skills, Regulatory Submissions, Medical Devices, Promotional Literature, Excel, Microsoft Office
Specialization
Health or science-related field engineering degree is a plus
Qualification
Graduate
Experience Required
Minimum 2 year(s)
ASIC Packet Processing Architect at Piper Companies
Saratoga, California, USA - Full Time
Skills Needed
Microarchitecture, Serdes, Networking Solutions, High Speed Interfaces, Design
Qualification
Graduate
Experience Required
Minimum 15 year(s)
Manufacturing Associate II (Downstream) at Piper Companies
Gaithersburg, Maryland, USA - Full Time
Skills Needed
Aseptic Processing, Chromatography, Aseptic Technique, Tff
Qualification
BSc
Resident Engineer - Networking at Piper Companies
Washington, District of Columbia, USA - Full Time
Skills Needed
Network Design, Presentation Skills, Scripting Languages, Jncip, Ccnp, Python, Rsvp, Operations, Routing Protocols, Design, Ccie
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Lead Product Manager (Credit Cards) at Piper Companies
McLean, VA 22102, USA - Full Time
Skills Needed
Communication Skills, Product Strategy, Credit Cards, Finance, Product Management, P&L Management, Digital Channels, Consumer Lending
Qualification
MBA
XSOAR Consultant at Piper Companies
Remote, Oregon, USA - Full Time
Skills Needed
Security Analysis, Performance Metrics, English, Parsing, Regular Expressions, Presentation Skills, Splunk
Specialization
Relevant Field
Qualification
Graduate
Experience Required
Minimum 4 year(s)
ERP Technical Specialist at Piper Companies
Raleigh, North Carolina, USA - Full Time
Skills Needed
Business Rules, Sql
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Wireless Engineer (30% Travel) at Piper Companies
New York, New York, USA - Full Time
Skills Needed
Enterprise Networking, Traffic Engineering
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Senior Systems Administrator at Piper Companies
Annapolis Junction, Maryland, USA - Full Time
Skills Needed
Security+, Rmf, Operating Systems, Directory Services, Active Directory
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Quality Assurance Specialist at Piper Companies
West Point, Pennsylvania, USA - Full Time
Skills Needed
Communication Skills
Specialization
Engineering science or related field
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Lead Product Manager - Credit Cards at Piper Companies
McLean, VA 22102, USA - Full Time
Skills Needed
Analytical Skills, Product Management, Finance, Consumer Lending, Product Innovation, Credit Cards, Strategy
Specialization
Business, Finance, Marketing
Qualification
MBA
TechOps Administrator at Piper Companies
Redmond, Washington, USA - Full Time
Skills Needed
Polygraph, Communication Skills, Active Ts/Sci Clearance
Specialization
Assist with user account provisioning certificate issuance and troubleshooting
Qualification
Trade Certificate
Experience Required
Minimum 1 year(s)
UC Administrator at Piper Companies
Miami, Florida, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
IT Specialist Senior at Piper Companies
Annapolis Junction, MD 20701, USA - Full Time
Skills Needed
Linux, Customer Service, Communication Skills, Contract Requirements, Deliverables, Conflict Resolution
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Contracts Support Specialist at Piper Companies
Colorado Springs, Colorado, USA - Full Time
Skills Needed
Active Ts/Sci Clearance, Jcids, Procurement, Budgeting
Specialization
Federal contracting and procurement
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Business Development Manager at Piper Companies
Remote, Oregon, USA - Full Time
Skills Needed
Radar, Launch Vehicles, Software, Communication Skills, Space Systems
Qualification
Graduate
MQ Administrator at Piper Companies
Annapolis Junction, Maryland, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
A mq administrator role
Qualification
Graduate
Experience Required
Minimum 7 year(s)
VMWare Administrator at Piper Companies
Quantico, VA 22134, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 4 year(s)
Packet Processor Architect at Piper Companies
Saratoga, California, USA - Full Time
Skills Needed
Architecture Modeling, Performance Tuning
Qualification
Graduate
Experience Required
Minimum 15 year(s)
MQ Administrator at Piper Companies
Annapolis Junction, Maryland, USA - Full Time
Skills Needed
Websphere, Dual Citizenship
Qualification
Graduate
Experience Required
Minimum 7 year(s)