Global Regulatory Specialist Job at Tobii Dynavox (Stockholm)

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Senior Regulatory Specialist

At GSK, we unite science, technology, and talent to get ahead of disease togethe...

Location

India , Bengaluru

Salary:

144750.00 - 241250.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Chemistry, pharmacy or other related biological science or technical bachelor's degree
English language skills
Knowledge of drug development and manufacturing and supply processes
Knowledge of worldwide CMC post-approval regulatory requirements
Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager
Service orientation, customer-focused

Job Responsibility

Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms
Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers
Will serve as a mentor/trainer for new team members
May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department
Independently and confidently executes agreed dossier strategy
Independently manages multiple project simultaneously
assignments will range in complexity but more complex work is expected
Independently completes data assessment to ensure dossier is fit for purpose
Identifies risks associated with submission data and information packages
Escalates issues with line manager that have business impact

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Annual bonus
Eligibility to participate in our share based long term incentive program

Fulltime

Regulatory Specialist II

At Bath & Body Works, everyone belongs. We are committed to creating a culture o...

Location

United States , New Albany

Salary:

64000.00 - 92400.00 USD / Year

Bath and Body Works

Expiration Date

Until further notice

Requirements

2-5 years’ related experience
Familiarity with formulated, hardline and softline consumer product regulations
Strong written and oral communication skills
Must be collaborative, motivated, and adaptable
Excels at managing competing tasks simultaneously without compromising accuracy or attention to detail
Proficient in Microsoft Office, Word and Excel and preferably SAP system
Bachelor’s degree or equivalent experience in related field

Job Responsibility

Accountable to understand and apply global regulations to ensure compliant products
Communicate ingredient/formula requirements to appropriate partners (internal and external)
Evaluate and resolve minor product compliance issues with cross functional partners
Perform reviews to confirm ingredients, formula, and product acceptability
Responsible for supporting SOP development and revisions as needed
Maintain relationships with contract manufacturers and suppliers
Evaluate and raise major issues to manager/supervisor
Awareness and understanding of regulations, industry, and technical issues
Perform research on regulatory-related topics appropriate to areas of accountability and gain foundational understanding of developing emerging technical issues
Support administration of issues communication and issues management documentation needs

What we offer

Robust medical, pharmacy, dental and vision coverage
Access to our onsite wellness center and pharmacy located at the Columbus, OH home office
401k with company match and Associate Stock Purchase with discount
No-cost mental health and wellbeing support through our Employee Assistance Program (EAP)
Opportunity for paid time off and paid parental leave
Access to family and lifestyle programs including a family building benefit, childcare discounts, and home, auto and pet insurance
Tuition reimbursement and scholarship opportunities for post-secondary education programs
40% merchandise discount and gratis that encourages you to come back to your senses

Fulltime

Regulatory Specialist

Charlie Gilmur with Robert Half is looking for a Regulatory Specialist to help s...

Location

United States , Newberg

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent relevant experience in the medical device manufacturing industry
extensive industry experience may be considered in place of a degree
Working knowledge of medical device regulatory frameworks across multiple regions, including U.S., Canadian, European, and other international markets
Experience preparing and maintaining regulatory documentation, technical files, registrations, and product compliance records
Familiarity with quality management system standards and risk management principles, including ISO 13485 and ISO 14971
Ability to assess engineering changes, product development updates, and labeling revisions for regulatory significance
Experience participating in internal audits, external audits, or regulatory inspections within a regulated manufacturing environment
Strong document control, organization, and cross-functional communication skills
Proficiency supporting quality assurance and regulatory compliance activities for medical device or closely related regulated products

Job Responsibility

Lead the preparation, organization, and upkeep of regulatory submissions and product files for domestic and international markets
Oversee product registration, licensing, and renewal activities, ensuring approval records remain current and traceable
Evaluate design or engineering changes to determine regulatory impact and identify when additional submissions or notifications are required
Partner with internal teams to review product labeling, instructions for use, and related documentation for compliance with applicable market requirements
Maintain quality system documents such as procedures, templates, and manuals so they remain aligned with current standards and business practices
Plan and perform internal audits, document observations, and follow corrective actions through to completion
Support external inspections and third-party audits by assembling required evidence and assisting with responses to findings
Monitor changes in global regulations and standards, assess operational impact, and communicate necessary updates to stakeholders
Contribute to post-market quality and regulatory activities, including complaint analysis, adverse event reporting support, and recall documentation when needed
Provide training and practical guidance to cross-functional teams on regulatory expectations, risk management, and quality system requirements

What we offer

medical, vision, dental, and life and disability insurance
401(k) plan

Specialist, Global Treasury Operations

The Global Treasury Operations professional plays a critical role in ensuring th...

Location

Italy , Bologna or Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Finance, Economics, Accounting, or related field
1-3 years of experience in treasury, finance operations, or treasury operations / treasury back office functions
Knowledge of treasury management systems (TMS) and ERP software (e.g., SAP, Piteco)
Familiarity with financial instruments such as FX, derivatives, and money market products
Strong skills in MS Excel
experience with data analysis and reporting tools is a plus
High attention to detail and accuracy in transaction processing
Strong organizational skills with the ability to manage multiple tasks under tight deadlines
Excellent communication and collaboration abilities
excellent teamwork abilities and the capacity to work effectively in an open space environment and ability to work independently when needed

Job Responsibility

Ensure timely and accurate settlement of financial transactions, including payments, loans
Process and verify treasury-related transactions in accordance with internal policies and external regulations
Monitor and manage trade confirmations and discrepancies with counterparties
Assist in daily cash flow operations, including forecasting and reconciliation of bank accounts
Support in executing internal funding transfers and ensuring optimal cash allocation across accounts
Collaborate with the treasury front office and middle office to monitor liquidity levels and meet funding requirements
Reconcile bank statements, transaction records, and financial positions to identify and resolve discrepancies
Work on the monthly reporting to provide a clear representation of the treasury KPIs
Support in managing the registration of new power of attorney holders with the bank
Support in managing the company credit card portfolio

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

Senior HR Specialist, Global HR Compliance & Talent Acquisition CoE

Plaud is building the next generation intelligence infrastructure and interfaces...

Location

Singapore

Salary:

Not provided

Plaud

Expiration Date

Until further notice

Requirements

Bachelor's degree in Human Resources, Business Administration, or a related field
5 years of progressive HR experience, with at least a year in a regional or global employment compliance or TA CoE function
Proven experience in designing and optimizing recruitment processes
Proven track record of managing employment compliance projects and ensuring adherence to multi-country labor regulations
Excellent written and verbal communication skills in English

Job Responsibility

Serve as a subject matter expert on global employment laws, workforce governance, and regulatory compliance across all countries and territories where Plaud operates
Partner with HRBPs, Legal, and regional People teams to assess, identify, and mitigate employment-related risks in current and new markets
Drive the development, implementation, and periodic review of global and regional employment policies, standards, and compliance frameworks
Provide proactive consultation and training to HR and business leaders on emerging compliance requirements and risk management best practices
Design and continuously enhance global TA frameworks, policies, and playbooks to improve hiring efficiency, productivity, and quality
Lead projects to optimize sourcing strategy, assessment methodologies, and selection tools, ensuring best-in-class candidate experience and hiring outcomes
Partner with Talent Acquisition teams globally to standardize metrics and governance — such as cost-per-hire, time-to-fill, and hiring quality benchmarks
Collaborate with Employer Branding and HR Analytics teams to position Plaud as an employer of choice in the AI and tech sectors through data-driven insights and market intelligence
Facilitate continuous learning initiatives to enhance recruiter and hiring manager capabilities in talent assessment and selection

What we offer

Market-competitive compensation
global exposure
vibrant, creativity-fueled work atmosphere

Fulltime

Senior Healthcare Regulatory Specialist (saMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...

Location

Spain , Barcelona

Salary:

Not provided

DocPlanner GmbH

Expiration Date

Until further notice

Requirements

Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
Experience with EUDAMED, CAPA systems, and post-market surveillance tools
Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
Strong communication skills with both internal teams and external regulatory authorities
Fluent in English
Spanish or other EU languages are a plus

Job Responsibility

EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

What we offer

Healthcare insurance
Wellness that works for you – from gym memberships to mental health support
Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge
ESOP (Employee Share Option Plan) after 6 months
Local Perks – Depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – lots of chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world
Flexibility That Works for You – Remote work and flexible hours

Fulltime

Senior Healthcare Regulatory Specialist (SaMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...

Location

Spain , Barcelona

Salary:

Not provided

Gipo

Expiration Date

Until further notice

Requirements

Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
Experience with EUDAMED, CAPA systems, and post-market surveillance tools
Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
Strong communication skills with both internal teams and external regulatory authorities
Fluent in English

Job Responsibility

EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

What we offer

Healthcare insurance
Wellness that works for you – from gym memberships to mental health support
Time off that counts – vacation, birthday, or just a day to recharge
ESOP (Employee Share Option Plan) after 6 months
Local Perks – meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world in a diverse and inclusive environment
Flexibility That Works for You – Remote work and flexible hours

Fulltime

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Global Regulatory Specialist

Job Description

Job Responsibility

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