Regulatory Affairs Generalist Job at Parexel

Regulatory Strategy & Government Affairs Lead

We're hiring an experienced Regulatory Strategy & Government Affairs lead to wor...

Location

United States

Salary:

Not provided

Stedi

Expiration Date

Until further notice

Requirements

3+ years in health tech, fintech, compliance, government affairs, or a generalist in-house role
Excellent judgment and work ethic
Strong writing
Ability to pick up new subject matter quickly
Knowledge of HIPAA transaction standards, CAQH CORE operating rules, and CMS requirements
Ability to extract key information from complex regulatory documents and translate into business strategy
Thrive in ambiguity and create structure from chaos
Independently design scalable processes from scratch
Business acumen to blend legal rigor with strategic persuasion
Relentless, resourceful, and professional

Job Responsibility

Drive Stedi's regulatory affairs strategy by developing deep subject matter expertise and building relationships with payers, regulators and industry standards bodies
Quarterback compliance workstreams as we expand into new product areas
Own the end-to-end process for identifying, escalating, and resolving payer connectivity issues that implicate HIPAA, CAQH CORE, and/or CMS requirements
Conduct research on healthcare and financial services regulatory questions, monitor relevant legislation and rulemaking activity, and draft comment letters for agency proceedings
Draft outreach citing specific, relevant regulation that compels action, advocate for favorable regulatory interpretations, and maintain excellent relationships with payers
Work directly with world-class external counsel when necessary
Represent Stedi in discussions with payers, clearinghouses, and regulators, influence industry standards and operating rules

Fulltime

Regulatory Affairs Generalist

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University Degree in a Scientific or Technical Discipline
A few years of experience in an industry-related environment
Experience in regulatory authority-facing roles
Regulatory Operations (Submission management) experience
Experience using Veeva Vault RIMS - strong plus
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken

Job Responsibility

Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
Coordinate health authority interactions and responses to questions
Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
Maintain up-to-date local national systems according to local legislation
Manage impact assessments for technical changes affecting marketing authorizations
Stay current on regulatory requirements and guidelines to ensure compliance
Support health authority inspections as needed
Provide technical and business consulting services within area of expertise
Complete activities within project scope, timeline, and objectives

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Quality Generalist

The Quality Generalist is a entry level position responsible for supporting vari...

Location

United States , Canton

Salary:

50000.00 - 70000.00 USD / Year

Fagron

Expiration Date

Until further notice

Requirements

College degree (science or engineering related major)
cGMP experience in a pharmaceutical manufacturing company (or similar) preferred
Basic problem-solving skills and use of Microsoft Office tools (Word, Excel, Powerpoint)
Ability to work in a fast-paced environment
Ability to handle a high volume of work and rapidly adapt to changing environment
Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management
Ability to take initiative, including asking for and offering help when needed
performs work independently without being prompted
Strong attention to detail and focus on quality, accuracy, and accountability

Job Responsibility

Develop efficient communication tools across departments to support consistent and priority release of products for patients and support day-to-day maintenance of the system
Support tracking and reporting of quality and operational metrics
Support creating and updating on-the-job trainings for the cGMP training system
Provide support on Lean Six Sigma projects to improve the QC laboratory and QA workflow
Participate in team meetings to assess additional needs of departments
Ensure cGMP documentation associated with work activities is complete
Supporting projects in each team as needed
Perform other related duties as assigned

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

New

Project Controls Coordinator III

Under the direction of the Supervisor Project Controls, the Analyst will perform...

Location

Canada , North York

Salary:

55.00 - 58.00 CAD / Hour

Randstad

Expiration Date

June 03, 2026

Requirements

Four Year Degree or combination of education and related experience
Minimum of 5 years of Project Controls or Project Management experience
Project Management professional designation is preferred
Experienced analytical skills including Earned Value Management
An independent worker within a team setting
Demonstrated professional engagement at a high level with work group, stakeholders, and contractors in a team setting
Proficient in the use of SAP, Oracle and MS office suite, intermediate+ Excel skills
Excellent communication, interpersonal, and organizational skills
Ability to effectively manage and prioritize workload, bring issues forward and develop working relationships at all levels of the organization
Detail oriented and understands the importance of data reconciliation

Job Responsibility

Analyze and maintain the project costs at the WBS level including control budget, incurred costs, commitments, and forecast
Provide the project team with accurate and timely cost information and reporting
Perform earned value measurements to anticipate forecast impacts
Perform monthly project close processes and prepare monthly project reports and comparative capital cost estimates for the project in Excel and EcoSys
Prepare and document project change orders timely in accordance with Project Management Office standards
Engage the Project Managers in meetings and discussions to review and reforecast project costs
Review cost transactions to ensure accurate project costs
Communicate with larger Controls team for the project
Liaise with Project Managers and Field Cost Analysts to ensure engagement with the project progress, changes, highlights and issues
Maintain the project Work Breakdown Structure such that it facilitates project execution and cost control during project execution and meets accounting requirements for asset creation and project closeout

Fulltime

New

Mechanical Engineer - Energy Solutions

Join a Team of engineers dedicated to working hand-in-hand with large manufactur...

Location

Canada , North York

Salary:

65.00 - 68.00 CAD / Hour

Randstad

Expiration Date

May 09, 2026

Requirements

Engineering Degree preferred, Chemical or Mechanical Engineering preferred
Membership in Professional Engineers of Ontario or similar professional organization is preferred
Proven skills in: leading and influencing without explicit authority
time management
Ability to work independently but work within team of like-minded professionals
Valid driver’s license with a responsible driving record is needed

Job Responsibility

Identify new contacts and conduct at large manufacturing facilities to for the purpose to arrange site visits
Attend joint-site visits with team members to support in the identification and quantification of potential energy savings projects
Balance multiple priorities: Able to effectively manage time and priorities, consistently delivering in firm annual savings targets
Quantify impact and secure buy-in: Build technical savings calculations, sometimes from scratch, to support project justification and persuade key stakeholders on execution of work
Provide solutions to complex problems: expertly analyze complex operations across various industries and synthesize available information to create solutions equally appealing to business and technical people
Forge long-term customer relationships: build and nurture professional relationships founded on unwavering trust and mutual respect, being a first-choice energy efficiency partner for your customers
Continuous growth and curious mindset: Proactively identify new savings opportunities to drive both short and long-term work and build a sales funnel for sustained growth
Drive results autonomously while thriving in a collaborative environment: Play a supporting role in managing a small group customer base and integrate into, and support broader Team to achieve personal and collective objectives

What we offer

Hybrid Work Model: in-Office (Monday, Tuesday & Thursday) Remote (Wednesday & Friday)

New

Senior Hardware Compliance Designer

Are you an experienced Electrical Engineer with a deep understanding of Electrom...

Location

Canada , North York, Ontario

Salary:

50.00 - 58.00 CAD / Hour

Randstad

Expiration Date

May 09, 2026

Requirements

Bachelor’s degree in Electrical Engineering or an equivalent combination of diplomas and work experience
6 to 10+ years of professional experience in hardware qualification or testing
Excellent knowledge of core EMC concepts, including Cabling, Grounding techniques, and Surge Protection
Demonstrated familiarity with railway (or similar industry) EMC and environmental standards
Proficiency in operating hardware test equipment and simulators used in the qualification process
Professional verbal and effective writing skills to ensure clear, concise, and unambiguous technical documentation and presentations
High degree of professionalism, strong ability to follow directions, use sound judgment, and keep meticulous track of all assigned tasks

Job Responsibility

Leading the hardware qualification, certification, and verification activities for new and revised products from planning through to customer acceptance
Conducting in-depth Electromagnetic Compatibility (EMC) tests on electronic devices according to industry standards (e.g., EN 61000 series, EN 50121 series, FCC, AREMA, MIL standards)
Performing environmental qualification tests (e.g., temperature, humidity, shock & vibration) on signaling electronic devices as per standards like EN 50125 and EN 50155
Participating in troubleshooting EMC-related issues and providing technical data and measurements to the design team
Preparing and driving comprehensive project documentation to customer acceptance, including the EMC Control Plan, EMC Compatibility Study, EMC Hazard Analysis, and EMC Test Report
Preparing hardware environmental qualification plans and reports, understanding the impact of requirements, and providing feedback on different technical approaches
Leading and managing subcontractors for specific on-site EMC measurements
Participating in ISA committee audits related to EMC and environmental requirements
Mentoring and developing junior team members within the department

What we offer

Impactful Work: Lead the qualification process for cutting-edge electronic devices used in safety-critical railway signaling systems
Technical Leadership: Be the in-house expert on EMC and environmental standards, influencing design and compliance strategies
Professional Development: Opportunities to develop junior team members and participate in high-level ISA committee audits
Global Exposure: Work with international standards and lead engagements with external subcontractors and customers for acceptance

Fulltime

New

Customs Compliance Specialist

Are you a trade compliance expert with a specialized background in the aviation ...

Location

Canada , Woodbridge, Ontario

Salary:

30.00 - 45.00 CAD / Hour

Randstad

Expiration Date

May 15, 2026

Requirements

Bachelor’s degree in Supply Chain, International Business, Aviation Management, or a related field (equivalent experience considered)
5+ years of dedicated customs/trade compliance experience, specifically within aerospace, aviation repair, or a high-tech regulated industry
Deep proficiency in EAR, HTS coding, and aviation-specific documentation (8130-3, EASA Form 1, teardown documentation)
Experience with NAV (Microsoft Dynamics) or similar ERP systems for tariff code management is preferred
A U.S. Customs Broker License, CCS, or specialized aviation compliance certification is a significant asset
Strong analytical ability, meticulous attention to detail, and the communication skills necessary to influence cross-functional teams in multiple countries

Job Responsibility

Ensure all aviation parts comply with U.S. Customs (CBP), EAR, FAA, and DOT regulations, as well as Canadian and UK (HMRC) requirements
Maintain expert-level accuracy for HTS codes, ECCN, country-of-origin, and valuation, specifically regarding airworthiness tags (8130-3/EASA Form 1)
Manage inbound consolidations and broker relationships (Expeditors/Freight Boy)
resolve PARs issues, and audit FedEx/broker invoices to minimize duty spend
Manage Item Card tariff codes in NAV
file and track duty recovery disputes
and perform gap analyses to identify process improvements
Serve as the primary point of contact for USCBP, BIS, and Census Bureau
lead internal and external compliance audits and maintain rigorous record-keeping

What we offer

6 month contract with the opportunity to become permanent
Hybrid work environment
Play a pivotal role in a highly regulated international supply chain, acting as a bridge between North American operations and UK-based parent company compliance
Opportunity to spearhead high-value projects, including the exploration of bonded warehouse setups and process automation within your first 120 days
Work within the Aerospace industry that values technical expertise and regulatory mastery

Fulltime

New

CNC Programmer - Laser Cutting and Forming

We are hiring for an experienced CNC Programmer – Laser Cutting & Forming. The s...

Location

Canada , St. Thomas

Salary:

26.55 - 39.83 CAD / Hour

Randstad

Expiration Date

May 25, 2026

Requirements

Post-secondary education in a relevant field of engineering
5 years of experience in CAD CAM programming
Experience with Laser machines, Press Brake machines, and CNC machining
Proficient in Fusion 360, Autocad, Solidworks, and Bisoft CAD software
Strong understanding of manufacturing processes and equipment
Excellent problem-solving and analytical skills
Ability to work in a fast-paced environment and meet deadlines
Strong communication and teamwork skills

Job Responsibility

Develop and optimize CNC laser cutting and forming programs for a range of materials including steel, aluminum and stainless steel
Utilize CAD/CAM software (AutoCAD, SolidWorks, Bysoft) to create and modify cutting plans for Bystronic laser cutting machines as well as bending plans for Bystronic forming equipment, and ensure efficient material usage
Analyze drawings and 3D models to create accurate and detailed programs for CNC cutting and forming operations
Set up and operate CNC laser cutting and forming machines, including loading material, adjusting settings, test runs and production runs (when necessary)
Monitor laser cutting and forming process to ensure parts meet specifications and quality standards
Maintain up-to-date knowledge of CNC laser cutting and forming technologies, machine capabilities and industry best practices
Responsible for preventative maintenance activities and troubleshooting/resolution of issues with lasers and forming equipment
Collaborate with planning, engineering and production teams to review project requirements and provide feedback on continuous improvement to increase productivity, material waste reduction and overall efficiency

What we offer

Competitive compensation $30-$40/hour
Opportunity to work with a dynamic team
Contract position to start with opportunity to extend or become permanent

Fulltime

Regulatory Affairs Generalist

Parexel

Location:

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 09, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Regulatory Affairs Generalist