Regulatory Affairs Specialist (Medical Devices), Accra, Align Technology
Role Responsibilities/ Responsabilités du rôle
Regulatory Affairs Specialist (Medical Devices)
Transforming Smiles, Changing Lives
Join a team that is changing millions of lives.
Transforming smiles, changing lives
At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what’s possible.
Ready to join us?
About this opportunity
The primary responsibilities include creating regulatory strategy for new products, managing filing related activities, providing regulatory expertise on daily issues, and interfacing with outside regulatory agencies.
This role reports into Manager Regulatory Affairs MEA
In this role, you will…
Manage assigned product registration activities; including filing determinations, Submission Files, Technical Files, and international product registrations focused on the SSA region.
Compile information from multiple sources for submissions, guiding the project teams in creating documentation for submissions, writing summaries and other necessary documentation for submissions.
Prepare annual licensing renewals and product registrations.
Establish Quality System related procedures and policies for Regulatory Affairs and update as necessary.
A broad understanding of the Regulatory requirements in the SSA region, Quality System regulations for medical devices (21 CFR 820 and ISO 13485:2016) and the MDD 93/42/EEC, its amendment 2007/47/EC and the MDR EU 2017/745 and guidance documents.
An excellent understanding of risk management for medical devices and experience with establishing risk management plans.
Provide guidance in complying with regulations; assist in developing rationale and documentation for new product development, product changes, testing, design reviews, labeling changes, packaging changes, material changes, etc.
Review and approve product labeling and promotional materials in accordance with regional and global regulations.
Represent Regulatory Affairs on project teams.
Attend product project team meetings, as necessary, providing regulatory guidance and review.
Review and approve document change orders.
Assist the Product Safety Team with making product safety determinations.
Provide input/direction on Medical Device Vigilance activities.
Conduct product corrections and removals in a timely manner.
Interface with international regulatory agencies.
Assist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products.
Work with Quality, Engineering, and Marketing to ensure product supply.
Interface with Customs Officials to resolve product holds.
In this role, you’ll need …
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to work independently.
Team player – project team experience.
Ability to do research and come up with creative solutions for regulatory challenges.
Excellent writing skills and ability to synthesize information to present internally as well as to regulatory agencies.
Demonstrated leadership; attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects.
EDUCATION and/or EXPERIENCE
BS in Engineering or Science or equivalent.
3-5 years in a regulatory role at a medical device company.
Extensive experience in performing all regulatory functions such as writing Technical Files, reviewing documentation for regulatory compliance, interfacing with international regulatory agencies as well as ISO notified bodies.
Software-related regulatory experience.
Extensive experience with maintaining Technical files.
Knowledge of FDA and EU regulations.
Computer skills including Word and Excel.
Sound like a good fit?
Great! Click the “Apply” link to let us know you are interested. Not the right fit? Don’t worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.
Align Technology is a publicly traded medical device company that is transforming smiles and changing lives. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world’s largest manufacturer of custom 3D-printed materials.
By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work – these are just some of the things employees say make Align Technology a great place to work.
We respect your privacy. Please review our Applicant Privacy Policies for additional information.
Global Diversity Statement:
At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. We live our company values by promoting healthy people and healthy communities. All with the intent of changing millions of lives, one unique smile at a time.
Equal Opportunity Statement
It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.
Postuler (Apply for the job) sur son site Internet: https://jobs.aligntech.com/jobs/28439?lang=en-us
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