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Senior Regulatory Affairs Specialist

Job Description

As a Senior Regulatory Affairs Specialist, you will be responsible for planning, coordinating, compiling, drafting, and filing US and EU regulatory submissions. Your role is to ensure that all submissions are accurate, high quality, and supported by literature and regulatory foundations. You will also facilitate review and ensure compliance with appropriate statutes, regulations, and guidelines.

Responsibilities

+ Plan, coordinate, compile, draft, and file US and EU regulatory filings.

+ Interface with third-party consultants and/or clinical research organizations in drafting and assembling regulatory materials.

+ Track submissions and collaborate with cross-functional teams to resolve questions or deficiencies from regulatory agencies or Notified Body.

+ Interface directly with regulatory agencies and/or Notified Body to facilitate the review and approval of regulatory applications.

+ Represent Regulatory Affairs in project meetings through all phases of product development, communicating regulatory requirements and impacts to the development team.

+ Review design and manufacturing changes for existing products, provide regulatory assessment, and communicate necessary changes to regulatory agencies and/or Notified Body.

+ Review and approve product labeling, advertising, and promotional materials to ensure compliance with FDA and other relevant regulations.

+ Stay current on domestic and international regulations, guidelines, and standards.

+ Perform additional tasks such as creating or revising departmental documents.

Essential Skills

+ Developing, writing, and organizing all aspects of pre-Sub/De Novo/510(k)'s and CE Submission under MDR.

+ Knowledge of current U.S. FDA and global (Canada, Australia, European Union, Japan, etc.) regulatory requirements within the medical device industry.

+ Five years of experience within medical device regulatory submissions.

+ Bachelor's degree in a related field.

+ Strong regulatory compliance expertise.

Additional Skills & Qualifications

+ Experience in a small manufacturing/R&D environment, including medical writing, clinical studies, and regulatory submissions.

+ Strong management, communication, and interpersonal skills.

+ Proficiency in MS Office, Internet, and databases.

+ Ability to work with minimal supervision in a busy environment.

+ Excellent writing skills, with the ability to write scientific summaries.

+ Ability to handle multiple assignments and perform in a diverse cross-functional team.

Work Environment

The work environment is fast-paced and requires the ability to manage multiple priorities. The role involves collaborating with diverse cross-functional teams and maintaining high standards of regulatory compliance. The use of MS Office, Internet, and databases is essential in daily tasks.

Pay and Benefits

The pay range for this position is $90000.00 - $120000.00/yr.

dental, health, vision, 401k

Workplace Type

This is a hybrid position in Valencia,CA.

Application Deadline

This position is anticipated to close on Jul 22, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.