Job Description
- Supporting normal business in new product introduction.
- Will support product recall activities.
- Will need to support all stages in full product lifecycle.
- Communication/interaction will be mostly all internal – regulatory to regulatory.
- Will write a regulatory plan/strategy and work with the customer to layout the geographies and the strategy built upon classification of geographies, registration requirements, alignment agreement on execution.
- Will prepare documentation and compile technical files (they won’t be doing any actual submissions).
- The documentation would be pretty basic (ie. a declaration stating the product will withstand extreme conditions/temperatures in the middle east for example).
- Additional duties/opportunities: Always lots of room for continuous improvement in both regulatory and quality processes.
- Products are mostly all OEMs (made specifically for their customer’s product , they also have some private label and generic products but mostly OEM.
Qualifications - Experience with medical device regulations and quality systems requirements for US and EU
- Highly prefer strong international registration experience
- Experience working with Class I/Class II products
- Experience working directly with regulatory, legal, R&D, manufacturing, and marketing departments
- Experience with Technical writing, such as regulatory plans/strategies and Technical Files
- Experience with US FDA regulations and EU MDR 2017/745 requirements, such as design controls, applying harmonized standards, and meeting essential requirements
- Knowledge of applicable regulations and registration requirements
- Knowledge of post-market and adverse event reporting requirements
- Need someone who can look at a process and identify where we can improve, then run with a project independently/without instruction to do so. This could be quality or regulatory processes such as registration processes or marketing claims processes that have opportunities for improvement
- Bachelor’s degree with experience in quality/regulatory
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.
Diversity, Equity & Inclusion
At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Are Embedded Into Our Culture Through
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Job Tags
Contract work,