Manager, Regulatory Affairs (Companion Diagnostics)

The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide input to the Regulatory or cross-functional team on regulatory matters.

This is a Remote opportunity 

Pay Range: $120,000 - $150,000/ year, 10% Bonus (The final offer and compensation package for this role may vary depending on the candidate's geographic location.)

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

· Medical/Prescription Drugs

· Dental

· Vision

· Flexible Spending Accounts (FSAs)

· Supplemental Health Plans

· 401(k) Plan – Company match dollar-for-dollar up to 5%

· Employee Stock Purchase Plan (ESPP)

· Supplemental Life Insurance

· Dependent Life Insurance

· Short- and Long-Term Disability buy-up

· Blueprint for Wellness

· Emotional Well-Being Resources

· Educational Assistance

· Paid time off / Health Time

Responsibilities

• 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.

Qualifications

Required Work Experience:

• Minimum of Bachelor’s degree in a relevant healthcare/scientific field.
• A minimum of 4 years of direct experience in preparing in vitro diagnostic (IVD) regulatory submissions including PMAs, De Novo Requests, , 510(k)s and/or IDEs is required. Experience in working with Immunohistochemistry (IHC) assays, oncology assays, or companion diagnostics is a plus.
• A minimum of 7 years of related experience is required with a Bachelor's degree, OR, a minimum of 5 years of related experience is required with a Master's degree or higher.

Preferred Work Experience:

At least three years of experience working in regulatory affairs or related roles on CDx projects within the IVD industry.

• 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.

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.

Skills:

• 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.

Education

• Bachelor’s Degree (Required)

Licenses or Certificate:

• Regulatory Affairs Certification (RAC) (Preferred)