Regulatory Affairs Specialist II

Santa Ana, CA

Direct-Hire, Full-Benefits

Hybrid Role

Job Summary:

The Regulatory Affairs Specialist II will assist and coordinate the compiling, preparation and assembly of regulatory submissions and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. This is a full-time, direct-hire role located in Santa Ana, CA with a hybrid some days work from home schedule.

Essential Duties:

• Assist in the renewal and maintenance of, but not limited to, the following:

• Local, State and National Regulatory licensing and registration renewals

• Import/Export Permits

• Assist in the identification of, but not limited to, the following:

• Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements

• Notification to management of new and revised documents referenced above

• Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following:

• Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.)

• US FDA 510(k) Premarket Notifications

• US FDA Drug Master Files and annual updates

• Technical Files for EU and EU AR

• Registration Documents for China and ROW

• Understanding, implementation of all the regulations assigned in each country in which products are registered and distributed.

• Assisting in insuring that regulations related to in-country registration is to clearly stated to ensure compliance with product registration for new or registered products.

• Assisting in ensuring that distributors of IS products are observing the regulations as mandated by regulatory authorities in-country, including that of products that are registered

• Assist with, but not limited to, the following:

• Internal/External and Customer Audits

• Change assessment to product design, specifications, or product manufacturing processes

• New Product Committee (NPC) Design Control

• Product Recalls

• Field safety corrections

• Mandatory Device Reporting (MDR)

• Mandatory Problem Reporting (MPR)

• Vigilance Reporting (EU)

• Adverse Events Reporting (Worldwide)

• Writing and/or revising regulatory related standard operating procedures

• Preparing monthly reports on product registration status

• Assist in the approval of, but not limited to, the following:

• Changes to procedures

• Product promotional material

Job Requirements:

• B.S. or B.A. preferred.

• Two to Three years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry.

• GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, MDR 2017/745, ISO harmonized standards (EN14971, EN 13408, EN 13824).

• Quality control methodology, QA controls systems and production methodologies.

• Experience in cell, tissues culture and/or embryology. Experience can be from education or industry.

• Ability to obtain cooperation from other groups and lead cross functional teams.

• Experience with risk management and Failure Mode Effects Analysis (FMEA).

• Understanding of validation of processes and equipment, methods validations, process investigations, technical evaluation.

• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.