Product Regulatory Compliance Specialist
Dexian DISYS, Westbrook, ME, United States
Job Title
Product Regulatory Compliance Specialist (Hybrid) Job details
Posted: 16 April 2026 Location: Westbrook, ME 04092 Reference: 1000922 Job description
Duration:
12 months (possible extension) Location:
Westbrook, Maine 04092 Pay Rate:
$27 - $28.57 hourly on W2 Job Summary
Work Schedule: 7am - 3pm ET Experience Level: Intermediate (4 to 6 years) Top required skills
Good analytical skills Ability to learn systems Intermediate Excel skills (ability to use formulas and create pivot tables) Focus on accuracy: data review and processing, reporting & declarations for multiple countries, schemes and time periods Organized: generating and organizing large number of files and documentation Have skillsets
Experience with some company ERP systems (e.g., SAP) Experience generating standard reports out of systems EPR reporting
Working on specific EPR application to load raw data, trigger calculation and reporting files Review files for data accuracy Transferring EPR data onto reporting portal at required frequency SAP
Generate standard reports for EPR calculations Run material master reports to collect product specifications Excel
Work with complex files using formulas and pivot tables Integrate data from multiple sources to generate combined views & reports In This Role You Will
Coordinate regulatory documents, ensure that submissions are timely and regulatory objectives are met Research scientific and regulatory information in order to write, edit, and review reports Compile all materials required for submissions, license renewals, and annual registrations Keep informed of professional and global regulatory information Work with governmental regulatory agencies Coordinate and prepare document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company and internal audits and inspections Compile all materials required in submissions, license renewal and annual registrations Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance Monitor and improve tracking/control systems Keep abreast of regulatory procedures and changes Potentially direct interaction with regulatory agencies on defined matters Recommend strategies for earliest possible approvals of clinical trials applications What You Need to Succeed
Self-starter with ability to work independently, initiates and coordinates projects and meets deadlines within a changing, fast-paced environment Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills Pays close attention to detail, handles confidential information with discretion and possesses a can-do attitude Strategic-thinker, goal- and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships with all levels of an organization Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk Facilitates and participates in process improvements across teams and organizations You meet the physical requirements that go with working as a Regulatory Specialist – extensive sitting, phone and computer use Company information and equal opportunity statement
Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results. To learn more, please visit https://dexian.com/. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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Product Regulatory Compliance Specialist (Hybrid) Job details
Posted: 16 April 2026 Location: Westbrook, ME 04092 Reference: 1000922 Job description
Duration:
12 months (possible extension) Location:
Westbrook, Maine 04092 Pay Rate:
$27 - $28.57 hourly on W2 Job Summary
Work Schedule: 7am - 3pm ET Experience Level: Intermediate (4 to 6 years) Top required skills
Good analytical skills Ability to learn systems Intermediate Excel skills (ability to use formulas and create pivot tables) Focus on accuracy: data review and processing, reporting & declarations for multiple countries, schemes and time periods Organized: generating and organizing large number of files and documentation Have skillsets
Experience with some company ERP systems (e.g., SAP) Experience generating standard reports out of systems EPR reporting
Working on specific EPR application to load raw data, trigger calculation and reporting files Review files for data accuracy Transferring EPR data onto reporting portal at required frequency SAP
Generate standard reports for EPR calculations Run material master reports to collect product specifications Excel
Work with complex files using formulas and pivot tables Integrate data from multiple sources to generate combined views & reports In This Role You Will
Coordinate regulatory documents, ensure that submissions are timely and regulatory objectives are met Research scientific and regulatory information in order to write, edit, and review reports Compile all materials required for submissions, license renewals, and annual registrations Keep informed of professional and global regulatory information Work with governmental regulatory agencies Coordinate and prepare document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company and internal audits and inspections Compile all materials required in submissions, license renewal and annual registrations Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance Monitor and improve tracking/control systems Keep abreast of regulatory procedures and changes Potentially direct interaction with regulatory agencies on defined matters Recommend strategies for earliest possible approvals of clinical trials applications What You Need to Succeed
Self-starter with ability to work independently, initiates and coordinates projects and meets deadlines within a changing, fast-paced environment Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills Pays close attention to detail, handles confidential information with discretion and possesses a can-do attitude Strategic-thinker, goal- and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships with all levels of an organization Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk Facilitates and participates in process improvements across teams and organizations You meet the physical requirements that go with working as a Regulatory Specialist – extensive sitting, phone and computer use Company information and equal opportunity statement
Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results. To learn more, please visit https://dexian.com/. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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