Manager, Regulatory Affairs; Companion Diagnostics

Position: Manager, Regulatory Affairs (Companion Diagnostics)
Job-:
Quality Assurance

Location:

Marlborough, MA, United States Workplace:
Remote daily

Schedule:

Full time, Day Posted:
Regular or Temporary:
Regular Weekly

Working Hours:

40.00

Salary Minimum:
Salary Maximum: AIP Target %: 10

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 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 Power Point 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…