Regulatory Specialist Job at Novitium Pharma (East Windsor)

Regulatory Specialist

The Regulatory Specialist is responsible for promoting compliance with regulator...

Location

United States

Salary:

61300.00 - 99620.00 USD / Year

Healthfirst

Expiration Date

Until further notice

Requirements

High School Diploma or GED
High school diploma or equivalent with at least four (4) years of health care experience
Strong knowledge of CMS and/or New York State DOH regulations
Compliance experience within a managed care environment
Working knowledge of project management
Intermediate MS Word, Excel, PowerPoint, Adobe Acrobat and corporate email systems
Ability to build and maintain positive relationships with cross-functional teams and interact with all levels of management
Time management, critical/creative thinking, project management, communication, and problem-solving skills

Job Responsibility

Promotes compliance with regulatory requirements
Meets with the Regulatory department to organize pre-survey deliverables and conduct reviews of materials
Interacts with and represents the business unit
Responds to auditor requests and audits outcome results
Identifies organizational risks and helps implement process improvements
Manages, coordinates, and participates in the implementation of contract changes for all lines of business pertaining to Utilization Management/Care Management/Appeals & Grievances departments
Ensures that all process and contract changes are reflected in departmental policies and procedures
Reviews Healthfirst policies, procedures, and correspondence to ensure compliance with CMS and DOH regulations
Monitors all Utilization Management/Care Management/Appeals & Grievances corrective action plans (CAPs) through completion
Reviews timeliness of all Utilization Management/Care Management/Appeals & Grievances monitoring reports to assess for compliance with regulatory time frames and develops CAPs if non-compliance is observed

What we offer

medical, dental and vision coverage
incentive and recognition programs
life insurance
401k contributions

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

Regulatory Specialist

The Regulatory Specialist ensures all regulatory policies, documentation systems...

Location

United States , Lancaster

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher in Food Science, Dairy Technology, or a related field
1–4 years of regulatory experience within the food industry
dairy experience preferred
Strong knowledge of food regulations, labeling, quality systems, or R&D processes
Exceptional computer skills and ability to work across multiple databases and software platforms
Better Process Control School certification preferred but not required

Job Responsibility

Manage document control processes to ensure accuracy and compliance
Support and maintain regulatory and quality systems
Interpret regulatory requirements and assess impacts on products and processes
Handle customer regulatory requests, nutrition, label claims, and related documentation
Manage export-related requests, including country suitability reviews, ingredient breakdowns, and export compliance requirements
Review product labels to ensure regulatory accuracy
Develop customer-requested regulatory documents and reports

What we offer

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

Regulatory Specialist

Join our Regulatory Affairs team and play a key role in ensuring compliance and ...

Location

Poland , Kraków

Salary:

Not provided

Edgerton Dental Clinic

Expiration Date

Until further notice

Requirements

College degree in a related technical discipline with 5+ years of professional experience
Direct experience in Dangerous Good regulations (as ADR, IMDG, IATA, other)
Good problem-solving skills
Strong written and verbal communication skills
Excellent interpersonal and communication skills and a proactive, self-motivated approach, collaborative mindset and positive attitude
Proficiency in Excel and familiarity with AI tools are considered assets

Job Responsibility

Manage small to medium projects representing in Dangerous Good area
Independently prepares, coordinates and secures all necessary permits, documentation needed for regulatory compliance
Ensures compliance with existing Dangerous Good laws, regulations, permits pertaining to health, safety and environmental control
Creates business value and competitive advantage through broad regulatory knowledge
Support supervisor or other regulatory personnel with special projects
Monitor regulation changes to ensure continued compliance
Maintain and share knowledge
May represent the RA department in project team meetings

What we offer

Attractive salary (Base pay & Variable Plan) and benefits package (private medical care, life insurance, stock purchase, lunch subsidy, sport cards)
Flexible working arrangements with hybrid model of work (approx. 60% from the office and 40% from home)
Thrive in our matrix organization, working across Europe with various teams and cultural backgrounds
Strong teamwork and diverse interactions
Personalized plans with rapid progression
Professional growth supported by active committee for different career levels
High employee satisfaction and responsive feedback
Continuous learning and technical training incl. subject matter experts’ training, soft skills and management training and LinkedIn learning
Assistance for international candidates and candidates living outside of Krakow
Social events such as family events and charity auctions

Fulltime

Regulatory Specialist

The Regulatory Specialist ensures all regulatory policies, documentation systems...

Location

United States , Lancaster

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher in Food Science, Dairy Technology, or a related field
1–4 years of regulatory experience within the food industry
dairy experience preferred
Strong knowledge of food regulations, labeling, quality systems, or R&D processes
Exceptional computer skills and ability to work across multiple databases and software platforms
Better Process Control School certification preferred but not required

Job Responsibility

Manage document control processes to ensure accuracy and compliance
Support and maintain regulatory and quality systems
Interpret regulatory requirements and assess impacts on products and processes
Handle customer regulatory requests, nutrition, label claims, and related documentation
Manage export-related requests, including country suitability reviews, ingredient breakdowns, and export compliance requirements
Review product labels to ensure regulatory accuracy
Develop customer-requested regulatory documents and reports

What we offer

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

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 Specialist IV

About Fairweather Fairweather is a trusted service provider in Alaska, deliveri...

Location

United States , Anchorage

Salary:

Not provided

Doyon

Expiration Date

Until further notice

Requirements

Senior level, typically 7+ years of experience
Understands advanced aspects of discipline and is viewed as an expert in each field
Applies broad range of competencies to develop solutions to complex problems
Influences others to achieve objectives
Often provides specialized/technical/functional guidance to others within department and/or business asset
Self-motivated
Technical writing skills
Attention to detail
Be familiar with local, state, and federal spill reporting requirements
Be familiar with local state tundra disturbance reporting requirements

Job Responsibility

Provides regulatory planning, permitting and compliance support
Participates in team project execution to ensure that all tasks related to environmental review/permitting at the local, state, and federal levels are integrated into current project planning efforts, implemented, secured and in compliance
Ensures compliance with internal environmental and regulatory procedures (compliance assurance, operations excellence)
Develops environmental contracting, regulatory, and permitting strategies
Maintains and enhance federal, state, and local agency relationships with specific emphasis on environmental review, permitting processes, environmental stewardship, surface management, as well as land access
Coordinates the collection of and analyzing regulatory metrics

What we offer

Supportive and collaborative work culture
Opportunities for professional development and career growth
Commitment to employee safety and well-being
Retirement Plan: 401(k) up to 4% company match
Employee Assistance Program (EAP): Free counseling and support service

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

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