Represent GRA with respect to the device constituent part of drug-device combination products.
Ensure regulatory conformity of the device is met during development, registration and changes through the product lifecycle
- Provide strategic and operational regulatory device input internally in regulatory and to cross functional teams, and other stakeholders.
- Provide regulatory device input to the development of global regulatory strategies in collaboration with the CMC Lead.
- Participate in drug-device development and LCM activities in cross functional project teams representing the device constituent part.
- Identify and inform GRT and project teams about ad hoc and complex regulatory issues/risks/constraints and liaise with the team members to ensure any issues are addressed. Advise on alternative solutions and risk mitigations.
- Strategically plan and prepare device input for interaction with regulatory authorities.
- Responsible for regulatory compliance of the device documentation supporting regulatory submissions and LCM activities.
- Responsible for planning device deliverables to regulatory submissions and ensure regulatory compliance of the submission package in relation to the device.
- Drive and compile the device regulatory submission file for NB opinion.
- Attend Q&A with regulatory authorities.
- Evaluate change controls to determine the level of change and provide input to renewal of marketing authorization for changes where applicable.
- Conduct regulatory intelligence and advice management and stakeholders of the impact of proposed and newly finalized regulations, guidelines, standards, and on review committee recommendations.
- Develop and advance (both in and outside GRA) the organization's policy and procedures for regulatory affairs and device compliance.
- Participate in due diligence activities.
- Provide training and mentoring for less experienced colleagues.
- Represent Leo Pharma in applicable business associations (Efpia and CPC), industry working groups or standard organizations.
- Lead and drive optimization of cross-functional processes where the device constituent part has an interphase .
- Master's or bachelor's degree within science e.g. pharmaceutics, biomedicine, biomedical engineering. Master's preferred.
- 10 years of experience within regulatory affairs-medical devices or drug-device combination products.
- Experience with driving and leading projects.
- Extensive knowledge of Regulation (EU) 2017/45.
- Extensive knowledge of FDA 21 CFR 820
- Extensive knowledge of EN ISO 13485:2016 especially the design control process.
- Extensive knowledge of relevant MDCG guidance and FDA guidance documents.
- Moderate knowledge of EN ISO 14971, ISO 10993-1, IEC 62336 and relevant product standards.
Ready to learn more about LEO Pharma?
- Extensive knowledge of medical device development and LCM, and familiarity with the drug development process.
- Experience working with CMO's. Advanced understanding of combining regulatory scientific, and business requirements and communicate risks and constrains.
- Experience interacting with numerous stakeholders and navigating in a cross-cultural environment.
LEO Pharma has been pioneering medical innovations for more than 110 years. Today, LEO Pharma looks to constantly improve and extend what is possible for the benefit of patients. Our rapidly expanding product portfolio and pipeline includes global therapeutic areas in psoriasis, eczema, skin infections, acne, rosacea and, most recently, rare disease.
LEO Pharma believes in challenging the status quo, so we approach dermatology "beyond the skin." Our global innovation ecosystem includes internal research and development, digital health via the LEO Innovation Lab, based in Copenhagen, and the LEO Science & Tech Hub, housed in Cambridge, Mass.
As we look to shape our U.S. footprint now and in the future, we pride ourselves on our agile and entrepreneurial environment. It allows passionate people to collaborate and push the boundaries of science in hopes to provide solutions for patients.
We offer a competitive compensation package, 401k match, vision, dental and health insurance, annual bonus, three weeks' vacation to start, a culture that emphasizes work-life balance, both paternity and maternity leave, an on-site game room, free membership to the on-site gym, plenty of coffee machines and - most of all - a FUN and celebratory work environment.
Let's wrap this up
If you are interested in joining a small, growing and nimble company, and help shape the future of medical dermatology, then send in your resume today!
At LEO Pharma, we welcome and consider applications from all qualified candidates because we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions for LEO Pharma and meet the needs of the wonderfully diverse marketplace we operate in.
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer committed to an inclusive and diverse workforce that creates a better future for our global communities. Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Thank you for your interest in career opportunities at LEO Pharma Inc.
LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels:
- the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite
- via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com"
- screening and interactionby telephone and through the Microsoft Teams platform.
- LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.
- Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.
- LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.
If you have any questions about LEO Pharma Inc. and the application process, please email the company's U.S. People and Communications team at [email protected] .