- Ogłoszenie wygasło 21 dni temu
- Umowa o pracę
- Specjalista (Mid / Regular)
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.
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About this opportunity
The primary responsibilities of Regulatory Affairs Specialist EMEA include supporting and creating regulatory product registration dossiers for new products, managing filing related activities, providing regulatory expertise on daily issues, and interfacing with outside regulatory agencies.
In this role, you will…
- Executing assigned product registration activities; including filing determinations, Technical Files, and international product registrations.
- 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 and Support annual licensing renewals and product registrations.
- Establish Quality Management System related procedures and policies for Regulatory Affairs and update as necessary.
- 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 product labeling and promotional materials in accordance with global regulations.
- Represent Regulatory Affairs on project teams.
- Attend product project team meetings, as necessary, providing regulatory guidance and review.
- Provide input/direction on Medical Device Vigilance activities.
- Conduct product corrections and removals in a timely manner.
- Assist management in planning regulatory activities, identifying roadblocks, strategizing on various regulatory paths for new products.
- Support Post Market Surveillance activities
- Work with Quality, Engineering, and Marketing to ensure product supply.
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.
- BS in Engineering or Science or equivalent.
- 4 - 6 years in a regulatory role at a medical device company.
- A broad understanding of the 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, EC MedDev guidance documents (and other EMEA regulations as a preference).
- 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.
- experience with maintaining Technical files.
- Computer skills including Word and Excel.
Sound like a good fit?
Great! Click on the "apply" button 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.