Regulatory Affairs Data Specialist Job at LANXESS (Manchester)

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

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 Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

New

Regulatory Affairs Specialist - Technical Writing

The Regulatory Affairs Specialist (Technical Writing) is primarily responsible f...

Location

United Kingdom , Keele

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in a life science or equivalent
Minimum 5 Years’ experience of medical writing within the pharma or medical device industry
Experience of writing clinical evaluation reports and PSURs in line with the EU MDR 2017/745 and MDCG guidance documents
Experience of conducting systematic literature searches and reviews
Experience of writing regulatory submissions including dossiers for EU MDR submission and/or US FDA Q-submissions

Job Responsibility

Primarily responsible for completing assigned clinical evaluation reports (CER) and other technical writing projects in a timely manner to meet business needs
Collaborate (write, review, and edit) with R&D, clinical, technical and regulatory teams on the creation of clinical evaluation reports, pre-submissions and other documentation intended for regulatory submissions
Conduct systematic literature searches for product-related data, including favourable and unfavourable data
Critically appraise and analyse clinical data from various sources (e.g. clinical investigations, post-market activities and vigilance systems)
Contribute to benefit-risk profile analysis for devices and show conformance to general safety and performance requirements
Conduct thorough quality control (QC) checks of documentation to ensure accuracy and consistency prior to approval
Contribute to discussions focused on gaps identified in available clinical data and support with any proposed strategies to address them
Ensure all technical writing is prepared and compliant with applicable requirements (e.g. EU MDR 2017/745, FDA Q-submission guidance, ISO standards, MDCG guidance)
Collaborate cross-functionally to ensure the accurate drafting and presentation of technical content within clinical evaluations and technical documentation
Provide technical writing support for global submission dossiers

What we offer

Company events
Company pension
Employee discount
Free or subsidised travel
Free parking

Regulatory Affairs Specialist

This position will provide Regulatory Affairs (RA) support for product remediati...

Location

United States , Tempe

Salary:

34.00 - 37.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

A minimum of 3+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems is preferred
Experience with European Medical Device Regulations is preferred
Experience with Kits and Procedure Packs is preferred
Excellent written and oral communication skills
Proven computer skills (Microsoft Word, Excel, PowerPoint, Project, Outlook)
Demonstrated problem solving and analytical skills
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy
Solid project management skills

Job Responsibility

Provide Regulatory Affairs (RA) support for product remediation projects, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR
Provide support for global product registrations and related regulatory affairs activities
Execute project activities based on applicable products and systems which are designed to ensure that the product development process adheres to all regulatory requirements
Utilize project planning skills to initiate, plan, and execute regulatory projects and submissions with support of supervisor
Manage change and be flexible when providing solutions
Collaborate with regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships
Understands and has working knowledge of European Medical Device Regulations
Supports US and international product submissions/registrations
Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements
Develops, documents and implements a regulatory strategy plan around remediation goals

Fulltime

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession
Fluent in English

Job Responsibility

Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle
Supervises data input activities and provides impact analysis and report conclusions and recommendations
Identifies the need for new regulatory procedures and SOPs
Identifies requirements and potential obstacles for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the potential impact of new guidance and regulations on a regulatory filing
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities
Provides regulatory information and guidance for proposed product claims/labelling

What we offer

Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts

Fulltime

Chemical Regulatory Specialist

A chemical raw materials company is looking to recruit a chemical regulatory spe...

Location

United Kingdom , Cheshire

Salary:

Not provided

VRS Regulatory

Expiration Date

Until further notice

Requirements

Some existing chemical regulatory experience (SDS authoring, classifications, labelling etc)
CLP, GHS, REACH compliance, labelling, compliance checks, supplier liaison, DG, customer enquiries, questionnaires, regulatory support, advice, data management, regulatory research

Job Responsibility

Ensuring products are compliant with chemical regulations (CLP, GHS, REACH, DG etc)
Learn about application regulations (regs impacting customers’ final products)
Compliance check new raw materials
Manage chemical / regulatory data
Author SDSs and labels
Answer customer regulatory enquiries
Complete customer questionnaires
Liaise with suppliers
Keep abreast of regulatory developments that may impact any products
Contribute to project work eg accreditations, sustainability

Regulatory Affairs Specialist

This position will be working in the BD Interventional Surgery Business Unit on ...

Location

United States , Warwick

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). B.A. or B.S. in other field acceptable with appropriate level of experience
Minimum 1-2 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies
Proven ability to resolve problems and to make appropriate regulatory decisions
Good oral and written communications skills - analytical thinking and technical writing
ability to work on cross-functional teams
ability to manage several parallel deliverables
Proficient in using Microsoft Word, Excel, PowerPoint, and Project
Strong communication and project management skills
Must be able to handle multiple tasks with attention to detail with limited supervision
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills

Job Responsibility

Assess necessity for reporting changes to FDA/Notified Body for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices. Sends out notifications of change to Notified Body as required
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders
Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards
Maintains regulatory databases/systems for key regulatory data
Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential product or process impacts
Provides regulatory support during internal/external audits and inspections
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide
Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance
Carry out the above tasks with minimal supervision

Fulltime

Regulatory Affairs Data Specialist

LANXESS

Location:
United Kingdom , Manchester

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 18, 2026

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Location:United Kingdom , Manchester

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Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:February 18, 2026

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