he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast's quality system and applicable regulatory requirements. 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. This position is also responsible for design control compliance for assigned products and will support development and execution of regulatory strategies per timelines to ensure clearance / approval in the assigned geographies.
Major Areas of Accountability- Support compilation of high-quality regulatory submissions for all products to expedite clearance/approval and sustain commercial availability for all products and support interactions with regulatory agencies.
- Participate on development project teams providing the team with 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 promotion material
- Work with Clinical and Quality to prepare post-market data for inclusion in periodic reports required by regulation and other post-market surveillance activities as needed.
- 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 the 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.
- Other duties as assigned.
Coordinator Role(s):Signature Authority:Basic Qualifications- BA/BS Degree or equivalent experience, scientific field degrees preferred
- 3+ years' experience in regulatory affairs in Medical Device industry
- Familiarity with FDA and EU 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
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, 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 Principals
At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:
- Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to 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.
- Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
- Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
- Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
- Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
- Community and Culture: A supportive work environment where everyone feels valued and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
- Competitive Compensation: The compensation range for this position is $107,203 - $160,804. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.
