Global Regulatory Strategy Lead for Medical Devices

Smith+Nephew; Mansfield (MA); On-site; USD 102,000 - 152,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Medical, Dental, Vision Coverage

Paid Holidays

Flexible Vacation Time

Parental Leave

Job summary

Smith+ Nephew is seeking a Senior Regulatory Affairs Specialist to shape regulatory strategies, secure global approvals, and ensure lifecycle compliance for medical devices. You will partner with cross‑functional teams to influence development and deliver patient‑centered healthcare solutions.

You will lead submissions, guide development and manufacturing, assess regulatory impact of changes, and mentor colleagues while building strong agency relationships.

Qualifications

• Bachelor's degree or equivalent in a scientific/technical field.
• 5+ years regulatory affairs experience in medical devices/healthcare.
• Strong knowledge of global regulatory requirements, medical products, and design controls.
• Experience managing regulatory submissions and working with agencies.
• Excellent analytical, writing, communication and project management skills.
• Ability to manage multiple priorities across diverse teams.
• RAPS Certification is a plus.

Responsibilities

• Develop and execute regulatory strategies for global registrations, clearances and approvals.
• Provide regulatory guidance to product development and manufacturing teams.
• Prepare, coordinate and manage regulatory submissions to global health authorities.
• Assess changes for regulatory impact and ongoing compliance.
• Build relationships with regulatory agencies through written and verbal communication.
• Support audits and contribute to regulatory intelligence and compliance initiatives.
• Develop and maintain regulatory procedures and mentor colleagues.
• Maintain regulatory databases and support additional regulatory projects.

Skills

Regulatory strategy

Regulatory submissions

Global regulatory knowledge

Project management

Technical writing

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree

Job description

Smith+ Nephew is seeking a Senior Regulatory Affairs Specialist to shape regulatory strategies, secure global approvals, and ensure lifecycle compliance for medical devices. You will partner with cross‑functional teams to influence development and deliver patient‑centered healthcare solutions.

You will lead submissions, guide development and manufacturing, assess regulatory impact of changes, and mentor colleagues while building strong agency relationships.