Senior Regulatory Affairs Specialist

Primary Function of Position

The Sr. Regulatory Affairs serve as the primary regulatory representative on product and project

teams supporting product lifecycle management activities. Responsibilities include developing

regulatory plans, reviewing design input/output documentation, identification of applicable

standards and guidance documents, performing regulatory assessments to determine the impact

of design/process changes, preparing regulatory submissions, maintaining regulatory filings and

licenses and interacting with regulatory agencies

Essential Job Duties

• Serve as the global regulatory liaison and primary point of contact for product and project

teams.

• Provide regulatory guidance to product teams, develop

regulatory plans, and review and approve product design

control documentation.

• Determine regulatory pathways and formulate regulatory

strategies for the U.S. and Canadian markets. Assess regulatory impact on design,

materials, labeling, packaging, manufacturing processes, and facility changes. Influence

and lead global regulatory strategies.

• Author and lead regulatory documentation and submissions, including U.S. FDA 510(k)

premarket notifications, internal Letters to File, pre-submissions with minimal supervision.

• Coordinate with technical experts to provide additional data/information requested by

regulatory agencies and prepare responses to facilitate regulatory approvals.

• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-

functional alignment and resolution.

• Collaborate with international counterparts to support global regulatory submissions,

approvals, and implementation rollouts.

Required Skills and Experience

• Minimum 8 years of regulatory affairs experience working in a medical device company

(can be in combination with a regulatory affairs master degree; e.g., Masters in

Regulatory Science)

• In-depth understanding of US Medical Device regulations and EU MDR, especially as it

related to Digital and SW related projects.

• Regulatory working knowledge of product lifecycle management, design controls, risk

management, verification and validation, and product labeling requirement

• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Strong verbal and written communication skills, proven

ability to translate technical documentation into effective

internal documentation, and regulatory submissions

• Team player who seeks to help and learn from colleagues

seeing the department success as their own

• Strong interpersonal and negotiation/influencing skills while maintaining a high level of

professionalism

• Proactively seeks to develop and become well-versed within the regulatory landscape.

Required Education and Training

Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical

Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical

device experience are acceptable.

Working Conditions

None

Preferred Skills and Experience

• RAPS Regulatory Affairs Certification (RAC) is a plus.