Manager, Regulatory Affairs & Quality Assurance Job at New York Embroidery Studio (Brooklyn)

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...

Location

Singapore

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific or technical discipline
6-10 years of experience in the medical device industry
Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives
Strong written and verbal communication skills
Experience with regional or international regulatory submissions preferred
Strong computer proficiency
Understanding of regulatory requirements across major APAC markets
Familiarity with mandatory Quality Management System requirements across APAC
General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage

Job Responsibility

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates
Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region
Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
Provide Regulatory and Quality leadership across all APAC markets
Recruit, build, and develop in-country RA/QA teams
Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements
Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC
Maintain regulatory databases
Direct the development and maintenance of regulatory systems and processes
Develop APAC regulatory strategies

What we offer

comprehensive and competitive range of benefits
health care benefits
retirement plans
work/life benefits

Regulatory & Compliance Manager

Location

Egypt , Cairo

Salary:

Not provided

PaxeraHealth

Expiration Date

Until further notice

Requirements

Bachelor’s degree in compliance, regulatory affairs, business administration, or related field
At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry
Strong knowledge of industry regulations, quality standards (ISO), and compliance processes
Experience with obtaining ISO 9001, ISO 27000, ISO 13485, FDA, MDR
Excellent English Language
Excellent organizational, leadership, and communication skills
Ability to manage multiple projects and deadlines in a fast-paced environment

Job Responsibility

Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies
Lead efforts to obtain and maintain certifications (e.g., ISO 9001, ISO 27000, ISO 13485, FDA, MDR, and other relevant quality/compliance standards)
Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement
Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings
Monitor and interpret changes in laws, regulations, and industry standards
advise management on compliance implications
Implement and manage the company’s Quality Management Systems (QMS)
Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks
Conduct regular internal audits and assessments to evaluate compliance and certification readiness
Drive continuous improvement in quality processes through monitoring, feedback, and corrective action

Fulltime

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Quality Assurance Specialist, Medical Communications

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experienced Medical Writer (1-2 years)
Scientific background and degree (PharmD, MD, PhD or Masters)
Knowledge of IT and digital solutions
Strong attention to detail and accuracy
Ability to manage and prioritize multiple, detailed activities
Results-orientated with fast and focused execution
Good communication, coordination and time management skills
Ability to work within a team or across multiple teams (including remotely) as well as independently
Fluent in oral and written English with high level of communication skills
Values teamwork, collaboration, and innovation

Job Responsibility

Cross check scientific information against cited references and ensure medical accuracy (fact check)
Ensure consistency with product label where applicable
Verify presence of essential information
Correct interpretation of scientific data from reference/sources
Alignment/formatting of content as per style guides/journal guidelines/congress guidelines
Ensure consistency of scientific content across different sections (including text, figures, tables)
Accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines
Confirm that every sentence is source annotated, and each source annotation matches with respective reference and vice versa
Ensure that information is presented in a neutral manner without any interpretations and/or author’s conclusion
Track work and communicate with client team on job reviews, prioritization etc., through emails and teleconferencing if needed

Manager, Medical Affairs

The Manager, Medical Affairs will provide expertise as well as clinical developm...

Location

United States , Skaneateles Falls

Salary:

120000.00 - 165000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum 5 years of related clinical experience required
industry experience preferred
Degree in related clinical field (Advanced Degree Preferred) or proven experience required
NP/PA/MD with primary and/or acute care experience such as ER, Urgent Care, or Hospitalist/internal medicine is ideal
Optometrist who displays sophisticated knowledge of physical assessment will be considered
Medical Affairs proven experience highly preferred
Active license in a U.S. state or territory in standing required with clinical expertise
Excellent written, verbal communication, and organizational skills
Effective and proficient presentation and teaching skills
Self-motivated, multi-tasking, with outstanding follow through

Job Responsibility

Serve as the medical and device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, and complaints
Provide accurate, balanced and timely clinical expertise to functional areas such as clinical development, R&D, marketing, manufacturing, quality assurance, regulatory affairs, and legal
Provide clinical expertise for creation and development of risk assessments and quality standards for product design history files
Devise novel approaches to address clinical and technical problems in clinical practice through development and modification of related medical devices
Assimilate voice of customer and clinical experience for design input with new product development and product lifecycle management
Develop and deliver relevant medical device training programs that support product implementation, training, and marketing efforts
Train internal customers on product application, disease states, and regional differences as required
Support product implementation process creation, maintenance, and controlled launch
Maintain familiarity of published literature as objective evidence for clinical trends and therapies related to impact on product lines
Coordinate with other Medical Partners to support Division Medical efforts.

What we offer

Comprehensive compensation and benefits packages
Medical and dental coverage starting 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) at a discount
401(k) Retirement Savings Plan with company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays and paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Manager, Medical Affairs

The Manager, Medical Affairs will provide clinical development and technical kno...

Location

United States , Skaneateles Falls

Salary:

120000.00 - 165000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum 5 years of related clinical experience required
industry experience preferred
Degree in related clinical field (Advanced Degree Preferred) or proven experience required
NP/PA/MD with primary and/or acute care experience such as ER, Urgent Care, or Hospitalist/internal medicine is ideal
Optometrist who displays sophisticated knowledge of physical assessment will be considered
Medical Affairs proven experience highly preferred
Active license in a U.S. state or territory in standing required with clinical expertise
Excellent written, verbal communication, and organizational skills
Effective and proficient presentation and teaching skills
Self-motivated, multi-tasking, with outstanding follow through

Job Responsibility

Serve as the medical and device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, and complaints
Provide accurate, balanced and timely clinical expertise to functional areas such as clinical development, R&D, marketing, manufacturing, quality assurance, regulatory affairs, and legal based on objective evidence and clinical experience
Provide clinical expertise for creation and development of risk assessments and quality standards for product design history files
Devise novel approaches to address clinical and technical problems in clinical practice through development and modification of related medical devices
Assimilate voice of customer and clinical experience for design input with new product development and product lifecycle management
Develop and deliver relevant medical device training programs that support product implementation, training, and marketing efforts
Train internal customers on product application, disease states, and regional differences as required
Support product implementation process creation, maintenance, and controlled launch when applicable
Maintain familiarity of published literature as objective evidence for clinical trends and therapies related to impact on product lines
Coordinate with other Medical Partners as needed to support Division Medical efforts

What we offer

Medical and dental coverage starting on day one
Basic life, accident, short-term and long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence

Fulltime

Quality Production Operations

Join the Quality Production Operations team to drive excellence in manufacturing...

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Knowledge of 2017/745(MDR) and 21 CFR 820
Knowledge of 13485: 2021
Strong technical troubleshooting and problem-solving skills
Excellent communication and collaboration abilities
Good English Level (writing and speaking)
Ability to work independently and collaboratively across multifunctional teams
Resilient and able to work effectively under stress and tight deadlines
Willingness to travel as needed
Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on production processes
Bachelor’s degree in engineering, or a related field

Job Responsibility

Oversee all processes related to the collection and review of the production records
Review the Device History Records related to medical device products and ensure the correctly storage of records
Support the Medical Device Production Manager in the planning of the production process
Ensure that all production activities comply with regulatory standards, quality control protocols, and company policies
Incoming Inspection: support the R&D ensure that the procedure for deciding when the lot under inspection is to be rejected or accepted
Equipment Management: manage the equipment calibration and archive the records
Non conformities management: open and manage the non conformities issued during the production process, correction and corrective action
Problem Solving: support the Medical Device Production Manager in the implementation of the corrective actions to minimize disruptions and maintain continuous production flow. Ensure that activities are correctly carried out and registered
Supplier Management: perform the supplier qualification and supplier monitoring process and support the Quality Assurance Manager during the audit at the supplier
Training: ensure that the training and guidance to production staff are correctly registered

Director of Quality and Regulatory Affairs

The Director of Quality and Regulatory Affairs leads the global QA/RA function a...

Location

United States , Burlington

Salary:

170000.00 - 180000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, technical, or related discipline
advanced degree preferred
8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience
5+ years of experience with Class I and/or Class II medical devices
Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions
Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls
Experience managing Quality Management Systems (QMS) for medical devices
Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred)
Demonstrated experience leading QA/RA teams, including talent development and performance management
RAC certification or equivalent is preferred

Job Responsibility

Lead the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy
Ensure compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle
Partner cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes
Contribute to the development and lead execution of the Quality strategy
Lead departmental planning and budgeting, optimizing resources and operational efficiency
Direct QA/RA staff, including organizational design, talent development and performance management
Develop and continuously improve quality programs, policies, and processes
Ensure Quality Management System (QMS) processes are established, implemented, and maintained
Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities
Oversee development and execution of global regulatory strategies for product submissions and lifecycle management

Fulltime

Select Country

Manager, Regulatory Affairs & Quality Assurance

New York Embroidery Studio

Location:
United States , Brooklyn

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 27, 2026

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