Senior Regulatory Affairs Specialist

Our client, a regulated medical device and life sciences organization is seeking a Senior Regulatory Affairs Specialist to join their team. As a Senior Regulatory Affairs Specialist, you will be part of the Regulatory Affairs and Compliance organization supporting Emerging Regulatory Issues and Global Regulatory Operations. The ideal candidate will have strong cross-functional stakeholder leadership, the ability to manage complex compliance initiatives with clear accountability, and a deep understanding of international regulatory requirements—aligning successfully in the organization.

What's the Job?

• Lead pan-franchise implementation of emerging global regulatory requirements across international markets.
• Assess new or changing international regulations to determine business impact, implementation needs, risks, and timelines.
• Coordinate cross-functional gap assessments and implementation plans to ensure regulatory requirements are incorporated into quality systems, procedures, labeling processes, and business operations.
• Support audit readiness by identifying compliance risks, quality system gaps, and remediation opportunities; track observations and commitments through completion.
• Drive regulatory operations and documentation activities, including change management, governance reporting, and process improvements that enhance efficiency, visibility, and compliance.

What's Needed?

• 5-7 years of experience in a regulated medical device, pharmaceutical, biotechnology, or other highly regulated industry within Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, Compliance, or a related function.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience supporting implementation of regulatory or compliance requirements across cross-functional organizations.
• Strong project management, organizational, and stakeholder management skills, including the ability to influence without direct authority.
• Ability to work independently, handle multiple streams simultaneously, and drive issues through resolution with effective mitigations.

What's in it for me?

• Opportunity to support continued market access by translating emerging global regulatory requirements into practical, compliant execution.
• Visibility into compliance governance through KPI dashboards, trackers, and management review metrics.
• Collaboration across Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and international affiliate teams to drive timely outcomes.
• Experience strengthening audit readiness by tracking remediation and supporting internal, external, and regulatory inspections as needed.
• Chance to serve as an interim lead for the Emerging Issues SME team, supporting prioritization, coordination, and delivery.

Upon completion of waiting period consultants are eligible for:

• Medical 
• Dental Plan
• Vision Plan
• 401(k)
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.