Senior Regulatory Operations Specialist
Coloplast has an exciting opportunity for a Senior Regulatory Operations Specialist to join our team!
As an individual contributor, the function of a Senior Regulatory Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual will lead in identifying data needed, obtaining these data and ensuring that they are effectively and consistently presented for product and facility licenses for Coloplast.
Major Areas of Accountability
- Prepare and maintain product listings, establishment registrations for US and Canada. Ensure all establishment and device annual updates happen in a timely manner.
- Process market authorization submissions (compilations, eCopying, filing). Ensure that associated 'user fees' are paid in a timely manner to avoid any negative impact on the regulatory submissions.
- Review and approve labeling changes. Interact with submission specialists to ensure alignment in labeling updates.
- Analyze regulatory environment changes and strategically communicate and implement new/changed requirements.
- Coordinate and document recalls or other RA related field actions. Report and update appropriate regulatory bodies as needed.
- Maintain well-organized RA records that allow ready retrieval of required information.
- Identify and implement improvements in the databases to further enhance existing databases per Coloplast needs.
- Provide input to contracts with external partners on design control and documentation requirements.
- Take lead in updating department procedures and documentation as needed and submit change orders.
- Provide GMP and Quality Management System, training to the applicable departments.
- Provide support during internal and external audits. Represent regulatory department for explanation of systems and processes.
- Track and report effectiveness and efficiency indicators related to Regulatory Operations.
- Manage GUDID coordinator and labeler accounts for UDI compliance
- Perform regulatory tasks related to product obsolescence
- BA/BS Degree in relevant technical discipline (Engineering, Science, medically related)
- 3+ years experience in medical device or pharmaceutical field
- Experience in CE Marking, FDA and Canadian submissions and regulations
- Expertise in Microsoft Office Suite (Word, Powerpoint, Excel)
- Ability to navigate enterprise systems and databases.
- Able to work well in cross-functional teams, independent yet a team player
- Strong Oral and written communication Skills, including technical writing at a professional level
- Demonstrated ability to work in dynamic environment, work under pressure and meet due dates required.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.
Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.