Position Summary

The Regulatory Affairs Specialist II supports the company’s regulatory initiatives to meet strategic short- and long-term objectives. This includes assisting with the preparation and submission of regulatory documents, maintaining compliance with applicable regulations, and supporting cross-functional teams during product development and post-market activities. The Specialist works closely with the Principal Regulatory Affairs Specialist and other team members to ensure regulatory requirements are met in a timely and compliant manner.

Primary Responsibilities

• Support the development and implementation of regulatory submission strategies.
• Assist with the preparation and maintenance of US regulatory submissions, including IDEs, PMAs, and associated supplements and reports.
• Help achieve/maintain CE Marking including MDR applications, maintaining technical documentation, and associated compliance activities.
• Support review of project documentation such as risk management files, test reports, and validations for regulatory completeness.
• Assess Engineering Change Orders (ECOs) for potential regulatory impact.
• Collaborate with cross-functional teams to address questions and support responses during submission reviews.
• Assist in drafting or updating regulatory standard operating procedures (SOPs).
• Support review of promotional materials for compliance with regulatory requirements.
• Contribute to clinical trial activities and documentation in line with good clinical practice (GCP) standards.
• Support internal and external audits and other quality system activities as needed.
• Perform all duties in compliance with applicable regulations, policies, and procedures, including timely documentation and training completion.
• Bring a collaborative, solution-oriented attitude to daily work and other responsibilities as assigned.

Education or Certification Requirements

• Bachelor’s degree in Scientific, Engineering, Public Health, or a related field.
• RAPs Certification preferred.

Professional Work Experience

• Minimum of 3 years of direct experience in Regulatory Affairs or a related field.
• Background in medical devices, biologics, or pharmaceutical industries, medical devices preferred.

Qualifications and Skills

• Strong understanding of FDA and EU regulations and guidance documents.
• Knowledge of Quality System requirements such as QSR, ISO 13485, GxP.
• Solid technical writing skills with experience preparing regulatory documentation.
• Project management skills and the ability to manage timelines within a team environment.
• Experience with software-based and/or sterile medical devices desirable but not required.
• Experience with clinical trials desirable but not required.

Other Essentials and Key Success Factors

• Demonstrated ability to work independently and as part of a cross-functional team.
• Strong organizational skills with attention to detail.
• Excellent verbal and written communication skills.
• Curious, proactive, and eager to learn within a dynamic, fast-paced environment.
• High degree of professionalism, integrity, and commitment to quality.

Travel

Minimal travel required.