Regulatory Specialist Job at Novitium Pharma (East Windsor)

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

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

Regulatory Reporting Specialist

Solaris is a tech company with a full German banking license. Our Banking-as-a-S...

Location

Germany , Berlin

Salary:

Not provided

Solarisbank

Expiration Date

Until further notice

Requirements

5+ years of professional experience in the regulatory reporting environment of a bank or financial institution in Germany
Hands-on experience in preparing and submitting regulatory reports
Knowledge in CoRep and/or FinRep is highly desirable
Practical experience working with regulatory reporting software
Familiarity with OneSumX (Wolters Kluwer) or Regnology would be a significant advantage
Solid understanding of accounting principles is a strong plus
Skilled at independently analyzing new requirements and translating them into concrete implementation projects
A proactive individual who sees challenges as opportunities and enjoys improving processes
Excellent communication skills and thrive both when working independently and as part of a collaborative team
Fluent in both German and English (German is a mandatory requirement for this role)

Job Responsibility

Core Responsibility: Regulatory Reporting: You will take charge of preparing and submitting of regulatory and statistical reports under the CRR and KWG
Regulatory Implementation: You will continuously monitor regulatory developments, analyze their impact on our organization, and take responsibility for the implementation of new requirements
Technical Process Improvement: You will drive the enhancement and automation of our reporting systems by defining and testing data requirements and optimizing existing workflows
Collaboration and Quality Assurance: You will work in close partnership with the Finance department and our Financial Data Department to ensure the consistency and quality of the underlying data
Business Growth Support: You will provide regulatory guidance for the onboarding of new partners and products, ensuring all new activities are compliant from the start
Stakeholder Communication: You will be a point of contact for auditors and supervisors, fostering a professional and transparent relationship

What we offer

Home office budget
Learning & development budget of €1000 per year and a transparent growth framework to support your career goals
Competitive salary and a variable remuneration program
Monthly meal allowance
Deutschland ticket subsidy
28 vacation days, increasing by 2 days after 2 years and 3 days after 3 years with Solaris
Opportunity to work abroad for up to 12 weeks per year

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

Regulatory Reporting Specialist

The candidate will be in charge of preparing and submitting regulatory reports t...

Location

Italy , Rome

Salary:

Not provided

Aegis FSI

Expiration Date

Until further notice

Requirements

Degree-qualified with a strong track record (3+ years) in regulatory reporting in the financial services industry
In-depth knowledge and proven experience with European banking prudential regulations
Fluent English language skills, both written and spoken
Ability to perform accurately and efficiently under pressure and meet tight deadlines
Strong analytical skills with the ability to accurately identify, evaluate, and manage regulatory requirements

Job Responsibility

Lead the analysis and interpretation of prudential regulatory requirements from the Bank of Italy and EU, ensuring compliance and alignment with internal policies
Develop and implement strategic reporting solutions, while supporting group-level regulatory reporting in close collaboration with the Shared Services Regulatory Reporting Team
Evaluate the regulatory implications of new business initiatives and evolving prudential regulations (e.g. Basel 3+)
Contribute to effective regulatory change management by promoting cross-functional understanding and supporting the design and coordination of consistent implementation plans
Drive the financial planning and execution of high-impact strategic and regulatory projects
Contribute to the preparation and delivery of ICAAP documentation and Pillar 3 reports in line with regulatory expectations
Act as the primary point of contact for the external regulatory service provider, ensuring effective collaboration and service delivery

Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
English proficiency at professional level
Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
Assist external stakeholders in the regulatory process per country requirements
Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

Regulatory Change Reporting and Governance Specialist

The Compliance Business Management is accountable to operate an effective, high ...

Location

Luxembourg , Luxembourg

Salary:

Not provided

Quintet Private Bank

Expiration Date

Until further notice

Requirements

Further professional Education (Masters / Professional qualification)
More than 5 years experience in a similar role
Solid understanding of Private Banking business and Management Company activities (including applicable regulatory requirements)
Good understanding of financial crime, conduct-related and operational regulatory environment applicable to the private banking and wealth management industry
Strong understanding of the regulatory changes and ability to translate into impact analysis within the business
Communication (Verbal & Written)
Critical Thinking & Problem Solving
Collaborative Teamwork
Agility in a Matrix Organization
Excellent communicator

Job Responsibility

Preparation and presentation of Compliance reports for Quarterly boards and specific governance committees
Standardisation/harmonisation of the locations reporting framework
Coordinating the internal watch team meetings, which bring together various subject matter experts to consider applicability of new/changing regulation
Maintain the process for analysing and monitoring regulatory change across the locations, in particular through engagement with our regulatory change vendor
Communicate regulatory change matters to the various bank entities
Monitoring of functional owned Audit and risk items issued across all locations and insure closure on defined target dates
Support with the development, implementation and continuous improvement of operational risk controls for the compliance function
Act as the Group Compliance function SPOC for any arising topics/projects requiring Compliance Business Management inputs
Ensure in-scope functions are aware of the regulations and are conducting an impact analysis
Prepare updates on new regulation to the Group Regulatory Steering Committee, and serve as committee Secretary

Energy Agreements & Compliance Specialist

Energy Agreements & Compliance Specialist to join the Long-term Optimization tea...

Location

Greece , Athens

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Law, Economics
Master's degree in Energy Law, Energy Markets, or Regulation are an asset
4+ years of experience in energy contract management, regulatory compliance, market operations, or energy economics
Strong understanding of EU/Greek regulatory frameworks (REMIT, EMIR, MAR, NRA decisions, DAPEEP rulebooks, Balancing Regulation)
Knowledge of regional market frameworks (Balkan region) is considered a plus
High attention to detail, structured thinking, and ability to manage multiple priorities
Proficient in MS Office, especially Word
Proficiency in English (written & spoken) and fluency in Greek

Job Responsibility

Draft Renewable Energy PPAs and BESS Optimization Agreements
Prepare, review, and maintain standard and bespoke agreements for energy trading and aggregation activities
Take full ownership of the agreements process
Collaborate with Legal, Risk, and Market Operations teams
Develop and maintain internal compliance procedures, checklists, and reporting documentation
Monitor EU and Greek regulatory developments
Ensure compliance with REMIT, EMIR, and relevant market frameworks
Support the development and maintenance of strong relationships with key clients and partners

What we offer

Competitive remuneration package
Ticket Restaurant Card
Group Health Insurance Plan
Preferential household electricity plan
Pension Plan

Fulltime

Regulatory Specialist

Novitium Pharma

Location:
United States , East Windsor

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 10, 2025

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Regulatory Specialist

Novitium Pharma

Location:United States , East Windsor

Category:Pharmacy

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:December 10, 2025

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United States , East Windsor

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Job Posted:
December 10, 2025