As our Regulatory Affairs Officer - Rest of world you ensure that market access for DORC products is sustained and expanded in accordance with business priorities for the assigned region or countries.
Main responsibilities:
- Ensure that the DORC product portfolio obtains and sustains regulatory approvals per business strategic plans per committed dates
- Maintain a thorough and up-to-date knowledge of regulatory requirements, applicable standards and post-market obligations throughout the product life-cycle and communicate upcoming changes timely to impacted stakeholders
- Develop pragmatic registration strategies that are compliant and ethical
- Complete submission packages for desired registrations based on the content of the Global Technical Dossiers, expanded with any locally required documentation
- Ensure and coordinate that any missing or incomplete documentation for a submission is timely shared with stakeholders, gets developed in a cross-functional effort, and gets archived in the Global Technical Dossiers
- Liaise with relevant regulatory bodies, registration partners, and other key industry bodies as required to satisfy regulatory requirements and meet ongoing regulatory obligations
- Monitor the regulatory status of responsible DORC products being marketed to ensure DORC complies with the local business and regulatory policies and alert management immediately when compliance is in doubt
- Manage 3rd-party registration agents to leverage extended resources to achieve DORC goals and target of registration projects
- Inform the business about any regulatory risks related to continuous supply of products for a country and find ways to minimize these risks by proposing practical solutions
- Ensure that the Global Submission Database is up to date
- Support the Regulatory Operations organization in answering RA Helpdesk questions
- Minimum 2 years in medical device industry, preferably in ophthalmology
- Solid understanding of medical device regulations in international markets
- Experience in the following regions is a plus: UK, Australie and Zwitserland
- Experience in Regulatory intelligence
- Ability to effectively communicate regulatory requirements to stakeholders
- Ability to plan and prioritize projects based on importance to the business and resource availability
- Ability to multi-task and methodically manage projects that enable the business to meet corporate objectives
- Ability to self-motivate, and work independently in a geographically separated multi-national and multi-functional team environment
- Collaborates effectively across a diverse network of strong personalities
- Open minded for improvement opportunities and change towards striving for best-in-class compliance performance
- Ability to think creatively, proactively identifying alternative solutions to problems
- Excellent communication/interpersonal skills required
- Fluent in English (written and spoken)
- Advanced level of Microsoft office suite applications
- Technical / professional qualifications
- Minimal Bachelor degree in a relevant field of engineering
Does DORC make you happy?
Does working for you mean working together? Realising surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organisation where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC is the place for you.
Would you like to know more about working at DORC? Then read on here.
What does DORC have to offer you?
At DORC, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:
- 27 holidays and 13 adv-days for a 40-hour full-time job
- 8% holiday pay
- 13th month
- Bonus scheme
- A travel allowance of € 0.23/km
- And a non-contributory pension, which means you will receive a substantially higher net salary
Did you know ...?
DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.
DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.
What else can you expect from us?
Every opportunity to learn and grow. Your own laptop and smartphone. And a fantastic company restaurant full of delicious, fresh products.
Will you be our new Regulatory Affairs Officer - Rest of world?
Are you up for this? Then apply directly via the red button! Do you still have questions? Then contact Monique Meiling our Global Recruiter: m.meiling@dorcglobal.com.