Regulatory Change Control & Data Specialist

Actalent; United States; Hybrid; USD 48,000 - 68,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) plan

Life Insurance

Disability benefits (short & long-term

Health Savings Account (HSA)

Transportation benefits

PTO / Vacation / Sick Leave

Job summary

Actalent is seeking a Specialist, Change Control & Data Retrieval/Collection to support the PEC portfolio. This hybrid role involves leading data retrieval across PLM, ERP, and QMS, validating datasets for regulatory submissions and internal reporting, and coordinating ECNs in QA systems.

You’ll collaborate with Engineering, Supply Chain, Regulatory, and external suppliers to ensure PEC data integrity. The position focuses on REACH, RoHS, PFAS, and PPWR compliance, with process improvements to

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience with engineering change management including change orders.
• Experience with medical device products or environment.
• Hands-on data retrieval and management using PLM, ERP, and QMS.
• Strong attention to detail for complex datasets.
• Ability to gather, analyze, and validate data from multiple sources.
• Excellent communication and collaboration across global teams.
• Strong organizational and project management capabilities.

Responsibilities

• Lead data retrieval across PLM, ERP, QMS and external suppliers for PEC data.
• Compile, cleanse, and validate datasets for regulatory submissions.
• Partner cross-functionally with Engineering, Supply Chain, Regulatory, Quality teams.
• Create and manage ECNs in QMS for PEC updates.
• Translate regulatory requirements into data needs.
• Support supplier engagement for declarations and certifications.
• Analyze data to identify gaps and drive resolution.
• Maintain project tracking tools and dashboards.

Skills

Cross-functional collaboration

Data retrieval & management

Attention to detail

Communication

Project management

Regulatory compliance understanding

Problem solving

Education

Bachelor's degree in Engineering or related field

Tools

Windchill

onePLM

ERP

Quality Management Systems (QMS)

Job description

Actalent is seeking a Specialist, Change Control & Data Retrieval/Collection to support the PEC portfolio. This hybrid role involves leading data retrieval across PLM, ERP, and QMS, validating datasets for regulatory submissions and internal reporting, and coordinating ECNs in QA systems.

You’ll collaborate with Engineering, Supply Chain, Regulatory, and external suppliers to ensure PEC data integrity. The position focuses on REACH, RoHS, PFAS, and PPWR compliance, with process improvements to