Regulatory Affairs Associate II

Regulatory Affairs Associate II

Location

North Chicago, Illinois

Category: Regulatory Affairs

Salary

Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

Job Description

Target PR Range: 29-39/hr

Depending on experience

Required

Education

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

• Required

Experience

• 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management

• Preferred

• 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing

• Experience working in a complex and matrix environment

• Strong oral and written communication skills

This contractor will work with internal and external partners in order to deliver products to patients. Job deliverables will include:

• Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.

• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions

• Manages preparation for agency meetings and manages content of pre-meeting submissions.

• Manages products and change control with an understanding of regulations and company policies and procedures.

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 3 to 5 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected.

• Experience Level = 3-5 Years

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.