This position will independently provide tactical and strategic leadership on complex projects within the Global Regulatory Affairs organization by actively contributing to the development and implementation of global regulatory strategies throughout the lifecycle of medical devices.
location: Lake Forest, California
job type: Contract
salary: $86.00 - 116.63 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms. Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
- Guide and influence technical groups in areas of product lifecycle management and enhancement.
- Support the negotiating and decision making with regulators and stakeholders with complex and high-risk projects.
- Overall responsibilities include lifecycle management change analyses, project support, and needed submissions. This role will be directly responsible for submissions within the EU, US, and Canada and will support submissions in all other markets as needed.
qualifications:
- B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
- MS degree and 4 years of regulatory experience.
- PhD and 2 years of regulatory experience.
- Experience in a medical device manufacturing facility/development laboratory preferred.
- Develop and implement regulatory strategy aligned with business strategy.
- Assess impact of new regulations and implement appropriate changes
- Support the Initiation and maintenance of appropriate communication within the RA function and stakeholders
- Interpret, apply and implement global regulations to projects and prepare regulatory submissions, particularly those in the US, EU, and Canada.
- Actively participate in project team meetings and provide leadership in meeting submission goals
- Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies
- Global responsibility for regulatory submissions (US, EU, and Canada)
- Responsible for support of global registrations
- Sound basis of Scientific (Training/Communications) knowledge in multiple areas
- Expert knowledge of regulations, and experience with interpretation and application
- Excellent written and verbal communication, presentation, and facilitation skills
- Strong negotiation skills and significant experience in interacting with regulatory authorities
- Risk identification and problem solving skills
- Change assessment experience for US and EU
- Submission experience for US and EU, including STeDs, 510(k)s, and PMAs
- Demonstrated leadership on complex regulatory strategies and projects
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
