Associate Regulatory Affairs Specialist (Interventional Urology)
Coloplast has an exciting opportunity for an Associate Regulatory Affairs Specialist to join our Interventional Urology team.
You will be responsible for design control compliance for assigned products and complaint reporting. This person will support development and execution of regulatory strategies per time lines to assure clearance / approval in the assigned geographies. This position will also prepare, monitor and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, change analysis, claims review and vigilance reporting.
Major Areas of Accountability
- Review complaints identified as potentially reportable to authorities and report or document a rationale for not reporting within the required time windows.
- Coordinate and document recalls or other RA related field actions. Report and update appropriate regulatory bodies as needed.
- Support interactions with regulatory agencies.
- Maintain well-organized RA records that allow ready retrieval of required information.
- Perform post-market surveillance and assist in risk management assessment.
- Supports compilation of high quality regulatory submissions for all Coloplast products to expedite clearance/approval and sustain commercial availability for all products.
- Participates on development project teams providing the team with information on applicable regulatory requirements.
- Support compilation of technical data to support CE-marking for assigned products.
- Support registration outside EU with appropriate documentation.
- Review and approve change controls for potential impact on regulatory status. Prepare submissions, supplements, amendments, and letters to file as needed to document rationale. Keep design history file (DHF) current.
- Review and approve labeling, promotional literature and other documents for regulatory compliance.
- Support audits and/or due diligence activities for regulatory affairs compliance for potential partners.
- Maintain RA processes, procedures, and instructions to stay current with changing requirements.
- BA/BS Degree or equivalent experience, scientific field degrees preferred
- 0-2+ years experience in regulatory affairs in Medical Device industry
- Familiarity with FDA regulations for medical devices. Prefer candidates with CE marking and Health Canada experience
- Experience with FDA interactions/presentations preferred
- Experience with recalls, adverse event reporting, biocompatibility, claims review, and post-market surveillance desirable
- Travel up 10%
- Applies basic knowledge of practices and procedures for specific area of responsibility.
- Develops solutions to routine problems of limited scope.
- Work is closely supervised. Follows specific, detailed instructions.
- Contributions are usually limited to task related activities.
- Internal interactions are primarily within the immediate work group. External interactions are primarily transactional or task oriented.
Required Knowledge, Skills, and Abilities
- Quality mindset-Right the First Time Focus
- Able to work well in cross-functional teams, independent yet a team player
- Demonstrates a continuous desire to understand, learn and implement up-to-date regulatory requirements, best practices and trends
- Analytical and able to work with complex data while still seeing the big picture
- Excellent oral and written communication skills with the ability to listen, articulate, facilitate & advocate
- Maintains an extremely high attention to detail and follow through
- Effective Organizational skills
- Demonstrates both creative and critical thinking skills
- Proficiency in Microsoft Office including Outlook, PowerPoint, Word and Excel
- Pro-active; high-performance and results orientation
- Ability to consistently work, manage and lead with ethical integrity
- Open-minded with a global mindset
- Embraces cultural differences within a global organization
- Agile and adaptable to change
- Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals
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.