Global Regulatory Strategy Architect

BD Mexico; Franklin Lakes (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Health Savings Accounts

Dental coverage

Job summary

BD in the USA NJ Franklin Lakes area seeks a Regulatory Affairs Strategist, Globalization, to implement worldwide regulatory strategies and partner with Business Units and Regions to enable compliant growth.

The role leads centralized governance of registration assessments, standardizes processes across regions, and stays current on global regulatory policy while traveling up to 25% as needed.

Qualifications

• Bachelor’s degree in science, engineering, or technology discipline required.
• 8+ years in the medical device industry, with at least 5 years in Regulatory Affairs.

Responsibilities

• Provide centralized regulatory governance related to the registration assessment process.
• Help to develop and standardize global regulatory registration assessments across regions.
• Act as a partner to Business Units and Regional Regulatory leaders for global processes.
• Coordinate and network across Business Units, Regions, Central RA for eIPRRA process.
• Harmonize key processes across RA operations and build communications channels.
• Identify common pain points and potential solutions in regulatory affairs.
• Stay apprised of global regulatory policy topics.

Skills

Regulatory knowledge

Stakeholder communication

Analytical thinking

Decision making

Project management

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/technology

Master's degree in business/management/tech

Job description

BD in the USA NJ Franklin Lakes area seeks a Regulatory Affairs Strategist, Globalization, to implement worldwide regulatory strategies and partner with Business Units and Regions to enable compliant growth.

The role leads centralized governance of registration assessments, standardizes processes across regions, and stays current on global regulatory policy while traveling up to 25% as needed.