Regulatory Affairs Specialist

Responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and applicable regulatory requirements. Prepares, monitors, and communicates status of regulatory submissions and performs duties related to regulatory affairs post-market surveillance, change analysis, claims review, and vigilance reporting. Ensures design control compliance for assigned products and supports development and execution of regulatory strategies per timelines to ensure clearance/approval in assigned geographies.

Responsibilities

• Support compilation of high-quality regulatory submissions for all products to expedite clearance/approval and sustain commercial availability; interact with regulatory agencies.
• Participate on development project teams, providing information on applicable regulatory requirements.
• Support compilation of technical documentation to support CE-marking for assigned products.
• Support registration outside EU with appropriate documentation and maintain regulatory registrations and licenses.
• Review and approve change controls, supplier evaluations, and non-conforming material reports 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 IFU, labels, and promotional material.
• Work with Clinical and Quality to prepare post-market data for inclusion in periodic reports and other post-market surveillance activities.
• Participate in CAPA investigations, root cause analyses, corrective actions, and verification of effectiveness.
• Coordinate and document recalls or other RA-related field actions; report and update appropriate regulatory bodies as needed.
• Participate in notified body, FDA, and internal audits, including audit responses.
• Review complaints identified as potentially reportable to authorities and report or document a rationale for not reporting within required time windows.
• Analyze, summarize, prepare, and present data for Management Review meetings.
• Maintain RA processes, procedures, and instructions to stay current with changing requirements.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Perform other duties as assigned.

Requirements

• BA/BS Degree or equivalent experience; scientific field degrees preferred.
• 3+ years’ experience in regulatory affairs in the Medical Device industry.
• Familiarity with FDA and EU regulations for medical devices; CE marking and Health Canada experience preferred.
• Experience with FDA interactions/presentations preferred.
• Experience with recalls, adverse event reporting, biocompatibility, claims review, and post-market surveillance desirable.

Skills

• 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, and advocate.
• Maintains 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.

Benefits

• Comprehensive medical, dental, and vision insurance plans.
• Company-sponsored wellness programs and mental health resources.
• Paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Competitive 401(k) plan with immediate company match vesting.
• Financial planning services and corporate discount programs.
• Generous paid time off, flexible work hours, and flexible work arrangement options.
• Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition programs including peer recognition, bonuses, awards, and special events.
• Supportive work environment with team-building activities, volunteer opportunities, and company-sponsored events.
• Sustainability strategy outlining ambitions for running the company in a more sustainable way.

Pay

The compensation range for this position is $107,203 - $160,804. Actual compensation is influenced by skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.