Medical Device Regulatory and Quality Consultant Job at PA Consulting (Melbourn)

Senior Regulatory Affairs and Quality Assurance Professional

In this role, you'll dive into a dynamic industry that actively collaborates acr...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

You are driven by the same purpose as us and want to contribute to improving the lives of patients around the world
You have a positive and curious mindset
You understand how to balance quality and pragmatism to ensure the best possible outcome for a given project
You are looking for a fun, friendly, and tolerant working environment in a purpose-driven company where your opinion matters
You have +5 years of experience working with quality assurance in the life science industry
You are interested in learning and have some knowledge within regulatory affairs
You pose a strong understanding and experience with design control, qualification and classification of medical devices, technical documentation and supporting project members in the principles of quality assurance
Strong knowledge or working experience with standards and regulations such as ISO 13485, ISO 9001, IEC 62304, GxP and/or CSV
Strong knowledge or working experience with quality principles such as testing, bug management, and risk-based approach in quality
You have a relevant educational background, e.g. biomedical engineering, software engineering or other relevant areas of science or engineering

Job Responsibility

Drive the regulatory strategy for digital health projects to enable global market launch
Support the development team in quality deliverables and activities according to our internal procedures based on IEC 62304 and ISO 27001
Ensure the quality of health software by adherence to the quality management system
Support and review safety risk management & cybersecurity deliverables
Provide regulatory and quality consultancy within development projects
Communicate with pharma-clients to align on issue resolution and deliverables
Participate in client audits
Using and shaping how to use AI tools in daily work

What we offer

A portfolio of meaningful products that impact patient lives at scale
Autonomy, trust, and support to do the best work of your career
An open, collaborative environment with talented peers across engineering, design, clinical, and regulatory
Career growth in one of the leading digital health scale-ups, alongside world-class pharma partners
The opportunity to leave your mark on the future of digital health
Copenhagen’s best view and best office espresso machine

Fulltime

Combination Product Quality Specialist Consultant

We are seeking an experienced Combination Product Quality Specialist to support ...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Prior management consultancy experience is highly desirable
A degree in life sciences, pharmacy, engineering, or a related discipline
Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
Proven experience authoring and maintaining quality and technical documentation in regulated environments
A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
Experience with supplier quality, audits, CAPA and document control
Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders

Job Responsibility

Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records
Supporting supplier qualification, audits and gap assessments
Acting as a subject matter expert on drug–device interactions and product integrity considerations
Interpreting and overseeing Container Closure Integrity Testing (CCIT)
Supporting the design and evaluation of stability and compatibility studies
Interpreting and applying evolving global combination product regulations
Supporting the preparation of regulatory submissions, technical dossiers and responses
Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
Contributing to process validation, equipment qualification and technical knowledge transfer

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Combination Product Quality Specialist Consultant

We believe in the power of ingenuity to build a positive human future. As strate...

Location

United Kingdom , Melbourn

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Prior management consultancy experience is highly desirable
A degree in life sciences, pharmacy, engineering, or a related discipline
Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
Proven experience authoring and maintaining quality and technical documentation in regulated environments
A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
Experience with supplier quality, audits, CAPA and document control
Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders

Job Responsibility

Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records, ensuring alignment and traceability across the product life cycle
Supporting supplier qualification, audits and gap assessments, ensuring compliance with global regulatory expectations
Acting as a subject matter expert on drug‑device interactions and product integrity considerations
Interpreting and overseeing Container Closure Integrity Testing (CCIT) to support sterility and product stability
Supporting the design and evaluation of stability and compatibility studies, considering both device and pharmaceutical components under real‑world conditions
Interpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‑market phases
Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies
Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
Contributing to process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity‑based initiatives
Annual performance‑based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Territory Account Manager

The Territory Account Manager role is responsible for driving growth by leveragi...

Location

United States , Evans

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Life Sciences, Marketing, or a related field
or equivalent combination of education and relevant experience
2-5+ years of sales experience in Life Sciences, including pharmaceutical, biotechnology, medical device, diagnostics, or laboratory solutions (level adjustable based on role seniority)
2+ years of channel, partner, or indirect sales experience, with demonstrated success managing distributor, reseller, or strategic partner relationships preferred
Proven track record of meeting or exceeding revenue targets through partner-led or hybrid (direct + channel) sales models
Experience supporting complex, consultative sales cycles, including multi-stakeholder decision-making and longer buying timelines
Working knowledge of Life Sciences regulatory and compliance environments (e.g., FDA, GxP, quality systems, data integrity expectations)
Demonstrated ability to build and execute joint business plans, pipeline development strategies, and partner enablement programs
Experience collaborating cross-functionally with marketing, product management, operations, and direct sales teams
Proficiency with CRM systems (e.g., Salesforce or equivalent), pipeline forecasting, and performance reporting

Job Responsibility

Meet and exceed all sales plans/ targets Develop, manage, and grow strategic relationships with authorized channel partners supporting the Life Sciences Channel portfolio
Drive bookings growth by executing partner-led sales strategies aligned to target customers and market segments
Enable channel partners through training, joint business planning, sales enablement tools, and product education to ensure effective market execution
Collaborate closely with channel sales teams to coordinate go-to-market initiatives, pipeline development, and account coverage
Support and execute tabletop events at key channel partners customer sites to drive product awareness and generate qualified leads
Maintain and manage demo units and sample inventory, ensuring timely availability for customer visits, trials and channel partner support
Identify new channel opportunities and recruit, onboard, and ramp qualified partners to expand market coverage and customer reach
Prospect and develop new customer relationships through cold calling, email outreach, networking, and client referrals
Expand business within the assigned territory by identifying opportunities, understanding customer needs, and presenting tailored solutions
Conduct in-person and virtual meetings, product demonstrations, and consultations

What we offer

Life, Health, Dental, Vision
401(K) including company match
Paid Time Off annually + Paid Holidays
Career Advancement Opportunities
Tuition Assistance

Fulltime

Senior Electrical Engineer

Imricor is seeking a Senior Electrical Engineer to lead the design, development,...

Location

United States , Burnsville

Salary:

100000.00 - 140000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor's degree in electrical engineering or related field (Master's degree preferred)
7+ years of experience in electrical engineering, with extensive experience in designing electrical systems for medical devices or capital equipment
Strong knowledge of analog and digital circuit design, power distribution, grounding, and shielding
Proficient computer skills including experience with schematic capture and board layout (preferably Altium), circuit simulation, and Matlab/Octave
Working knowledge of FDA design controls and IEC 60601 standards as well as overseeing testing completed by certified test labs
Ability to communicate concepts, ideas, and knowledge effectively and clearly to other individuals and teams
Strong analytical and problem-solving skills
Experience with Good Documentation Practices (GDP)

Job Responsibility

Consults and solicits feedback from internal stakeholders to identify customer needs and translate these requirements into designs
Leads electrical system architecture development and the design and evaluation of electrical components, enclosures, and systems to ensure availability, performance, and cost requirements are met
Develops optimized product solutions from concept to manufacturing through risk analysis (DFMEA), prototyping, and design iterations using engineering principles, human factors/usability, and design for manufacturability practices
Defines and executes electrical verification and validation plans, including bench testing, system integration, and agency testing
Leads root cause analysis and resolution of electrical issues discovered during development, verification, or clinical use
Supports reliability testing, tolerance analyses, and design-for-manufacturability activities
Responsible for successful product launch through product development process by working cooperatively with R&D, Design Assurance, Quality, Manufacturing, Regulatory, Clinical, and Marketing
Provides electrical engineering leadership during design reviews, risk analyses, and change control activities
Supports manufacturing transfer, supplier technical engagement, and post‑market engineering support
Supports product life cycle by addressing supply chain and quality issues in collaboration with Operation and Quality

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Group Head of Quality & Patient Safety

Working as part of the Group Leadership team, this role will promote and sustain...

Location

Ireland , Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Post-Graduate qualification, or equivalent, in Quality & Patient Safety
Seven years post-graduate experience in acute care setting
Minimum 3-5 years’ experience at management level
High professional standards in relation to confidentiality and ethics
Working knowledge of relevant legislation
Claims Management experience
Experience managing and working collaboratively with multiple internal and external stakeholders, as relevant to this role
The requisite knowledge and ability (including a high standard of suitability and management ability) for the proper discharge of the duties of the office.

Job Responsibility

Champion a visible and inspiring leadership style that drives a culture of continuous quality improvement across the Group.
Develop and maintain a collaborative close working relationship with the Group Clinical Director.
Serve as a core member of the Group Clinical Governance Committee.
Participate in Group Executive and Hospital Leadership, communicating and working with multidisciplinary teams to embed quality as a shared organisational value.
Act as a key conduit, strengthening communication lines between Group Executive leadership and hospital clinical teams.
Lead the Group’s Data Protection function, ensuring ongoing compliance with data protection legislation and safeguarding all personal data under BHG’s control, while acting as the primary liaison with relevant internal departments and with third-party partners and stakeholders on data protection matters.
Support and work closely with the Medical Societies, Medical and Nursing Leadership and other clinical groups to ensure the highest clinical standards and evidence-based best practice.
Prepare and present clear, insight-driven reports to the Group Clinical Governance Committee and Board, and others as requested.
Provide reports to the Group and Hospital Clinical Directors on all aspects of Quality as required.
Represent Quality and Patient Safety on Group projects, such as EHR implementation and Sustainability.

Fulltime

Sr Manufacturing Engineer

The Senior Manufacturing Engineer is a key site operations representative. The M...

Location

United States , Hayward

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Science of Mechanical, Biomedical or Electrical Engineering
3-5 years of experience in the Maintenance/Engineering field in a Pharmaceutical or Medical device manufacturing industry, preferred
Experience with statistical analysis with tools as Minitab or SAS, preferred
Experience with Microsoft Office Suite
Green Belt, Black Belt or PMP certification preferred
Ability to identify, define, and solve complex problems using a data-driven problem solving approach (i.e. DMAIC)
Technical writing ability for protocol generation, execution, and reporting to qualify processes and equipment
Strong technical skillset in the area of manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, GMP/GDP guidelines, and process validation
Excellent problem-solving, organizational, analytical and critical thinking skills
Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants

Job Responsibility

Drive continuous improvement in production performance, quality, and reliability through data-driven analysis, RCFA, FMECA, and statistical tools (SPC, SQC, DOE, Minitab, InfinityQS)
Provide hands-on technical support for manufacturing equipment and automation, ensuring optimal performance, maintenance, and compliance with regulatory and safety requirements
Lead nonconformance investigations (CAPA/NCR), including root cause analysis, corrective/preventive actions, effectiveness checks, and timely reporting to review boards and management
Partner with Manufacturing to implement lean principles and process improvements, supporting process validation (IQ/OQ/PQ), PFMEA, and overall product assembly optimization
Maintain accurate, compliant engineering and quality documentation (e.g., validation plans, protocols, reports) and prepare failure analysis reports to prevent recurring issues
Manage and support projects within budget and operational constraints, including capital planning, while delivering on Safety, Quality, Service, Cost, and Schedule objectives
Monitor and improve key production metrics (labor, yield, lead time, capability) through daily engagement with manufacturing and proactive data analysis
Ensure compliance with safety, GMP, and environmental regulations, including EHS standards, required training, and oversight of regulated systems and operations
Complete all required project updates, training, and administrative deliverables in a timely and accurate manner

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

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Medical Device Regulatory and Quality Consultant

Job Description

Job Responsibility

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