Regulatory Affairs Specialist

The Regulatory Affairs Specialist applies regulatory expertise and business knowledge to ensure medical devices are developed, registered, commercialized, and maintained in compliance with applicable regulatory requirements throughout the product lifecycle in the United States and Canada.

Serves as a regulatory affairs representative for United States and Canadian medical device regulatory activities, collaborating with global regulatory, quality, clinical, product development, and commercial teams.

Major Areas of Accountability

- Develop and execute regulatory strategies for new product introductions, product modifications, license maintenance activities, and market expansion initiatives in the United States and Canada.

- Prepare and submit FDA regulatory submissions including Traditional, Special, and Abbreviated 510(k) Notifications as applicable.

- Prepare, submit, and maintain Health Canada Medical Device License (MDL) applications, amendments, annual license renewals, and license maintenance activities.

- Conduct regulatory impact assessments and determine regulatory requirements associated with design, manufacturing, labeling, supplier, software, and process changes.

- Act as regulatory liaison for assigned geographies by ensuring that local regulatory requirements, pathways and registration needs are anchored in global regulatory strategies and executed at a local level, through transparent and clear communication and focus on collaborative work and solution.

- Review and approve product labeling, IFUs, packaging artwork, UDI content, and promotional materials to ensure compliance with FDA and Health Canada requirements.

- Assess transferability of global product claims per local requirements, and review advertising materials for regulatory compliance.

- Report information into applicable data management systems and maintain internal/external regulatory databases.

- Monitor and analyze emerging regulatory intelligence for the assigned geographies.

- Participate in development, maintenance and implementation of regulatory procedures, instructions and systems.

- Participate in preparation and execution of audits/inspections.

- Demonstrate mastery of the regulatory environment and develop strategies and tactical plans that align regulatory requirements with business objectives.

- Provide critical input on regulatory risks, gaps and opportunities for decision-making and develop pragmatic mitigation plans.

- Deliver high-quality regulatory submissions and regulatory assessments within established timelines while maintaining compliance with applicable regulations.

- Effectively prioritize assigned tasks/projects and navigate through matrix-based organizations and processes relevant to the function.

- Other duties as assigned

- Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

- Other job duties as assigned

Basic Qualifications

- Minimum Bachelor’s degree or equivalent relevant work experience.

- Minimum 2 years relevant work experience with direct exposure to regulatory affairs in the medical device industry, or other relevant regulated industry sectors.

- Cross-functional: business & value chain understanding, self-management, decision-making and critical thinking, collaboration & communication.

- Functional competencies: quality management system and processes, regulations, standards and sustainability, design control & validation.

- Ability to travel up to 10% for internal meetings, audits, inspections, and professional development activities.

Preferred Qualifications

- Master of Science degree in regulatory science, life science, biomedical engineering, or other relevant scientific or legal field.

- Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) or other relevant certification in regulatory affairs.

- Experience with FDA Class I and Class II medical devices.

- Experience preparing FDA 510(k) Notifications and Health Canada Medical Device License applications.

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 $110,000 - $150,000. 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.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world ´ s 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.

Visit us on Coloplast.com .

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

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.

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