We are seeking a highly skilled Senior Regulatory Affairs Specialist on behalf of an innovative medical device client. In this role, you will be at the forefront of regulatory science for medical robotics, supporting a deep culture of compliance while advocating for breakthrough innovations in urological surgery. You will provide critical regulatory guidance to cross-functional partners, develop global regulatory strategies for new and modified Class II and III devices, and prepare/submit regulatory submissions for the US, EU, and international (OUS) geographies.
...
Responsibilities:
Act as the lead regulatory representative on product development teams, communicating regulatory requirements and the impact of regulations to project teams.
Provide strategic input related to FDA and international product registrations and licensing requirements.
Develop global regulatory strategies for both new and modified products.
Monitor and interpret current and emerging regulatory requirements and international standards for the U.S. and Rest of World (RoW).
Support regulatory efforts to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR).
Independently identify and problem-solve regulatory and compliance issues, escalating to senior management as necessary.
Provide effective communication and rapid responses to internal customers while driving continuous improvement in internal processes.
Identify, develop, and mentor high-performing regulatory talent within the team.
Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from an RA perspective.
Execute US FDA 510(k) and Technical File creation and remediation, collaborating cross-functionally for required content.
Draft and execute comprehensive regulatory impact assessments for design control changes to existing products.
Working hours: 7:00 AM - 4:00 PM
Skills:
Advanced Degree: M.S. or Ph.D. in a technical or scientific area.
Device Classification: Direct experience working with both Class II and Class III medical devices.
Certification: Professional certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Soft Skills: Strong attention to detail, exceptional written/verbal communication, and robust analytical problem-solving skills.
Global Knowledge: Deep working knowledge of relevant ISO and EN standards, alongside a strong working knowledge of regulatory requirements for the US, EU (EU MDR), and other international geographies.
Education:
Bachelors
Experience:
7-10 years
Qualifications:
Education: Bachelor???s Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualifications.
Experience: Minimum of 6 years of experience with a B.S., or 4 years of experience with an M.S., specifically focused on regulatory submissions for medical devices.
Regulatory Compliance: Proven experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
Project & Time Management: Ability to work effectively on cross-functional project teams, manage multiple competing priorities, and run programs with minimal oversigh
Are you an experienced regulatory professional ready to lead compliance strategy for cutting-edge medical robotics? Take the next step in your career with an industry leader.
Click "Apply Now" to submit your resume for immediate, confidential consideration, or reach out to our recruiting team directly to learn more about this position.
Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
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 Spherion, 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 Callcenter@spherion.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, Spherion 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).
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.