Manager, Regulatory Affairs (Companion Diagnostics)

Education

• Bachelor’s Degree (Required)

Physical and Mental Requirements

• Strong verbal and written communication skills.
• Demonstrated success in motivating team members to reach objectives.
• Excellent interpersonal skills.
• Demonstrated PC experience with MS Word, Excel and PowerPoint

Knowledge

• US and EU regulatory submission requirements.

• Able to lead and drive change
• Exceptional attention to detail.
• Enthusiastic team player with an ability to collaborate with diverse teams.
• Exceptional time management skills.
• Strong ability to problem-solve and apply analytical thinking.
• Ability to manage conflict resolution.
• Organization skills
• Project and team management skills.
• Computer skills, including standard business software tools and typing
• Able to function in a matrix organization
• Flexibility to meet continuously changing priorities and challenges.
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
• Excellent oral and written communication skills, including the ability to discuss regulatory strategy and requirements with external stakeholders and senior management.
• Ability/Awareness of the importance of workplace diversity. Understand the gaps and differences that exist as well as their impact.
• Ability to effectively translate regulatory requirements into practical advice to cross-functional teams and other audiences. Crisp decision-making capabilities, delegation, managing tight deadlines, prioritization of work for self and partners.
• Supervisory or project team leadership experience is desired.
• May supervise team members at the Associate or Specialist levels.

Licenses or Certificate

• Regulatory Affairs Certification (RAC) (Preferred)

Preferred Work Experiencenice to have

• Regulatory or technical experience with Immunohistochemistry (IHC) assays
• Regulatory or scientific experience in oncology clinical indications
• Knowledge of European Union (EU) IVD regulation.
• Knowledge of international IVD and/or medical device regulations outside of US and EU.

Benefits Information

• Serves as the regulatory lead for companion diagnostic (CDx) programs, planning and preparing joint regulatory submissions (510(k), PMA, IDE, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports, with moderate supervision.

• Coordinates with pharmaceutical partners to ensure alignment of diagnostic and therapeutic regulatory strategies and timelines to ensure regulatory submissions are prepared and processed in a proactive and timely manner.

• Evaluates proposed premarket and post market changes for regulatory impact with minimal supervision.

• Responsible for regulatory review of protocols, reports and data for conformance with the requirements and expectations of health authorities.

• Responsible for regulatory review of labels, labeling, advertising and promotional materials.

• Maintain knowledge base of existing and emerging regulations, standards, or guidance documents and provide interpretive assistance to cross-functional teams.

• Compile and review regulatory submissions for completeness and quality. Ensure that submissions are in conformance with the latest industry and health authority submission standards.

• Assist with logging, tracking and filing of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains unduly outstanding.

• Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs.