Coloplast has an exciting opportunity for a Principal Regulatory Affairs Specialist to join our Interventional Urology team!

You will be responsible for design control compliance for assigned products and will develop and execute 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, recalls, biocompatibility, change analysis, claims review and vigilance reporting.

Major Areas of Accountability

• Apply advanced regulatory expertise to guide cross-functional team members and provide leadership to Regulatory Affairs personnel.
• Builds strategic partnerships to further departmental and organizational objectives.
• Maintains positive and cooperative communications/collaboration with all levels of internal and external personnel.
• Supports highly technical or major business segment product lines, special projects, or strategic initiatives.
• Plans, coordinates, and compiles high quality regulatory submissions for all Coloplast products to expedite clearance/approval and sustain commercial availability for all products.
• Interact with regulatory agencies as required in a timely and appropriate manner to respond to any questions during the review process.
• Participates on development project teams providing the team with information on applicable regulatory requirements and including biological evaluation/biocompatibility testing. Plans, documents, and communicates an appropriate regulatory strategy to support the planned launch strategy.
• Plan, coordinate, and compile technical files 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.
• Perform post-market surveillance and assist in risk management assessment.
• 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.
• Provide input to contracts with external partners on design control and documentation. Transfer required documentation for external projects to the Coloplast system.
• Perform audits and/or due diligence activities for regulatory affairs compliance for potential partners.
• Review complaints identified as potentially reportable to authorities and report or document a rationale for not reporting within the required time windows.
• Maintain RA processes, procedures, and instructions to stay current with changing requirements.

Competencies

• Applies mastery of in-depth knowledge in one job family or broader expertise in most areas of a job function.
• Develops solutions to complex problems that require the regular use of ingenuity and creativity. Ensures that solutions are consistent with organization objectives.
• Work is performed without appreciable direction. Exercises considerable latitude in determining deliverables of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results. May provide guidance about work activities to colleagues.
• Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. Failure to obtain results or erroneous decisions or recommendations would typically result in serious impact on customers and/or results and considerable expenditure of resources.
• Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs. Leads briefings with internal and external contacts.

Basic Qualifications

• BA/BS Degree or equivalent experience, scientific field degrees preferred.
• 6+ years of experience in medical or scientific field in Quality, Regulatory, R&D or equivalent
• 2+ years in Regulatory Affairs in the Medical Device industry (Class II-III)
• High level of familiarity with CE Marking, FDA and Canadian regulations, as well as applicable standards
• Ability to work flexible hours as needed for international communications
• Experience with Device-drug or Device biologic preferred.
• Experience with FDA interactions/presentations preferred.
• Experience with recalls, adverse event reporting, biocompatibility, claims review, and post-market surveillance desirable.
• Ability to interpret regulatory requirements into specific objectives and practical operational plans
• Ability to travel up to 10%, including international
• Proven ability to develop and execute effective regulatory strategies to ensure regulatory requirements are satisfied
• Experience in preparation, writing, and submission of Technical Files and Design Dossiers for CE Marked products, other US & international regulatory submissions experience is also preferred
• Working knowledge of up to date application for Post-market surveillance and risk management techniques

Required Knowledge, Skills, and Abilities

• Quality mind-set, 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, and 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 Principles.