Senior Regulatory Programs Manager – Sustaining & Compliance

bdx; Sparks Corner (MD); On-site; USD 150,000 - 239,000; Full time

Job summary

BD in Sparks, MD is seeking a Senior Manager to lead Sustaining & Compliance Projects within Regulatory Affairs. You will guide a team of regulatory project managers, ensure adherence to worldwide regulations, and align compliance efforts with business goals in a complex, high-regulation environment.

You will influence cross-functional teams, manage resource allocation, and mentor staff to strengthen regulatory capabilities while driving on-time deliverables and quality outcomes for Waters

Qualifications

• B.S. degree in a technical discipline (biology, microbiology, molecular biology, bioengineering) or higher.
• 7+ years in QA, regulatory affairs, or related field.
• 5+ years in management leading teams of 4+ members.
• 5+ years of project management experience, preferably RA related.

Responsibilities

• Connect regulatory strategies with business objectives with RA LT.
• Lead a team of regulatory project managers on sustaining and compliance projects.
• Monitor worldwide regulations and communicate risks and mitigations to stakeholders.
• Apply knowledge of Quality Management System (QMS) to assess project impacts.
• Oversee regulatory submissions when needed and ensure timely delivery.
• Represent Regulatory for Field Safety Corrective Actions and analyses.
• Engage with external bodies (trade associations, standards organizations) to support ADx.
• Allocate resources and develop capabilities to meet priorities and drive results.

Skills

Regulatory project management

Cross-functional leadership

Strategic thinking

Risk assessment

Team development

Communication with senior leaders

Education

B.S. in technical field

Job description

BD in Sparks, MD is seeking a Senior Manager to lead Sustaining & Compliance Projects within Regulatory Affairs. You will guide a team of regulatory project managers, ensure adherence to worldwide regulations, and align compliance efforts with business goals in a complex, high-regulation environment.

You will influence cross-functional teams, manage resource allocation, and mentor staff to strengthen regulatory capabilities while driving on-time deliverables and quality outcomes for Waters