"Alerted.org

12814BR

Title:

Associate Principal, Regulatory Affairs

Job Description:

Responsible for establishing and preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:

+ Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives.

+ Identify regulatory requirements for the markets identified in the regulatory strategy.

+ Develop and execute the regulatory strategy for the assigned market(s).

+ Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.

+ Communicate with regulatory agencies on administrative and routine matters.

+ Document, consolidate, and maintain verbal and written communication with the regulatory agencies.

+ Review change order documents and assess regulatory impact of product changes on US, EU, Canada, and/or international regulatory strategy/submissions, across product lines per MicroVention procedures.

+ Review promotional material and labeling for regulatory compliance as assigned.

+ Develop and maintain regulatory files and records.

+ Support and contribute to editing or revising regulatory Standard Operating Procedures (SOP) and Work Instructions (WI).

+ Support training for global regulatory processes and system implementations.

+ Build team cohesiveness by influencing and mentoring team members.

+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

+ Perform additional duties as assigned.

Salary Range

$110,000 - $130,000 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

Auto req ID:

12814BR

Location MV:

Aliso Viejo, California, USA

Department Name:

523-RAQA Regulatory

Qualifications:

1. Bachelor's degree in a scientific or technical discipline or relevant field of study.

2. Minimum five (5) years of relevant professional regulatory experience.

3. Strong technical writing skills as evidence by successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions and/or rest of the world (ROW) registrations across product lines.

4. Prior direct involvement interfacing with regulatory authorities through various stages of device life cycle.

5. Detail oriented.

6. Strong written and verbal communication skills.

7. Proficient computer skills, including MS Word, Excel, Outlook, and Teams.

Desired Qualifications

1. Advanced degree in a scientific or technical discipline or relevant field of study.

2. Experience in leading medium to large sized teams.

3. Ability to work well in a team environment.

4. Proven analytical abilities and organization skills.

5. Ability to comprehend technical documents and concepts.

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title:

Associate Principal, Regulatory Affairs

Posting Country:

US - United States

Salary Range:

$110,000 - $130,000 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.