Senior Regulatory Affairs Specialist Job at Beacon Hill (St. Louis)

Senior Regulatory Affairs Specialist

Are you interested in the future of digital health and medical device innovation...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Master’s degree within natural sciences, computer science, engineering or similar
5-10+ years in regulatory affairs (preferably both software and hardware medical devices)
Global regulatory market experience (e.g. EU, UK, Switzerland and MDSAP)
Demonstrated experience applying and interpreting relevant guidance and standards across software and hardware medical devices, including: IEC 60601 series, ISO 14971, IEC 62304, IEC 82304
Strong knowledge of cybersecurity and the evolving regulations for digital health and AI/ML devices
Adaptable and open to change and adjustments in agile work environments
Global mindset and experience with work relations in different cultures

Job Responsibility

Ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices
Involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices
Ensuring global device registrations
Working closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants
Active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks

What we offer

An attractive healthcare package to keep you fit and well
Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
Good work/life balance e.g., work from home policy for up to 2 days per week
Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
Social clubs, monthly Friday social activities, as well as various in-team activities

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen; Brussels

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

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

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...

Location

United States , Franklin Lakes

Salary:

59.00 - 63.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
Medical device and international registration experience is a must
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
Strong project management and communication (verbal, written) and skills
Able to independently handle multiple tasks/projects with minimum supervision
Self-starter with the ability to take over responsibilities
Team player, Attention to details, Highly result-oriented
Flexible and reliable personality
ability to manage stressful situations
High personal integrity and ethical standards

Job Responsibility

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Identify ways to improve the efficiency of current work process and best practices as necessary.

What we offer

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.

Fulltime

Senior Specialist, Regulatory Affairs

At Baxter, we believe every person—regardless of who they are or where they are ...

Location

United States , Deerfield

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, life sciences, or related technical field
2+ years of regulatory experience
Strong understanding of Veeva software (RIM and Promo Mats) systems
Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
Strong analytical skills, including digital competency
Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
Proofreading and editing skills
Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and problem solve

Job Responsibility

Under general supervision, responsible for Veeva RIM, Promo Mats system ownership
Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
Working with project teams on various data initiatives, addressing data challenges and gaps in current system
Identify areas for improvement/modification
Compile regulatory documents for FDA 2253 submission. Which includes tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements
Develop training material and liaise with cross function teams
Understand internal global processes supporting Regulatory systems
Coordinates and drives deliverable preparation
develops and maintains process models using standard methods and tools
manages and tracks communications, metrics, and reporting-related processes

What we offer

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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Specialist, Regulatory Affairs

The Senior Specialist resides within the Global Regulatory Affairs Systems Group...

Location

United States , Deerfield

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific, life sciences, or related technical field
2+ years of regulatory experience
Strong understanding of Veeva software (RIM and Promo Mats) systems
Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
Strong analytical skills, including digital competency
Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
Proofreading and editing skills
Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and problem solve
Applicants must be authorized to work for any employer in the U.S.

Job Responsibility

Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
Working with project teams on various data initiatives, addressing data challenges and gaps in current system
Identify areas for improvement/modification
Compile regulatory documents for FDA 2253 submission
Develop training material and liaise with cross function teams
Understand internal global processes supporting Regulatory systems
Coordinates and drives deliverable preparation
develops and maintains process models using standard methods and tools
manages and tracks communications, metrics, and reporting-related processes
Develops, executes and implements business processes for data integration, maintenance and remediation

What we offer

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
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Regulatory Affairs Senior Specialist

Summary: The role involves managing government affairs, regulatory compliance, l...

Location

Saudi Arabia , Western Province

Salary:

Not provided

Giza Systems

Expiration Date

Until further notice

Requirements

Affairs Management
Regulatory Compliance
Licensing
Administrative Relations
Relationship Building with Government Entities
Liaison with Government Bodies
Anticipating Regulatory Changes
License and Permit Management
Legal Coordination
Government Transactions Processing

Job Responsibility

Build and maintain active relationships with key government entities in the Western Region such as MISA, HRSD, ZATCA, Amanah, Balady, MOL, and others relevant to pulse's operations
Act as the official liaison and single point of contact between pulse and all government bodies in the region
Proactively anticipate regulatory changes and brief management on potential impact before they take effect
Manage the full lifecycle of all licenses, permits, and regulatory registrations for pulse's Western Region operations
Coordinate with the Legal team and external counsel on regulatory disputes, notices, or government inquiries
Oversee the processing of all official government transactions, ensuring accurate submission and follow-up

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