Manager, Regulatory Affairs – Americas (Ramsey, MN/Lewisville, TX)

The following is a detailed, but not exhaustive, listing of the tasks you will undertake in the role:

• Develop and implement regulatory strategy aligned with the company's business objectives, collaborating cross-functionally with other departments.
• Lead the preparation and submission of product approval submissions and registration files, pre-submissions, registration and listing, renewals and associated activities to ensure product market entry and compliance with international regulatory requirements.
• Maintain submission records and certificates of registration in a regulatory database.
• Acts as direct liaison between the Company and the various regulatory agencies. Maintains effective relationships with the FDA, Health Canada and LATAM regulatory authorities, representing the company during meetings, inspections and audits.
• Provide guidance and leadership to ensure regulatory and quality requirements are incorporated into design control and product development, production, and post-market activities across the organization.
• Acts as a regulatory representative on product development teams, communicates regulatory requirements and impact of regulations to project teams; Review and approve protocols, reports, and other technical documentation to support regulatory submissions.
• Lead regulatory projects and teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes.
• Mentor, train, and communicate with the Regulatory Affairs team, ensuring effective collaboration with other departments. Engage and manage outside contractors, as needed, to support regulatory activities.
• Manage reporting to the FDA (MDRs) and Vigilance Reports in the region; participate in company Complaint System.
• Review device labelling (including IFU), claims and promotional materials for compliance with global regulations; analyze and recommend appropriate change.
• Ensure Unique Device Identification labelling and registration in UDI databases is undertaken in compliance with regulatory requirements.
• Responsible for supporting the development, improvement and implementation of internal systems and procedures to support effective regional and global regulatory operations.
• Monitor regulatory intelligence and interpret changes in international regulations.
• Review design and manufacturing changes for compliance with applicable regulations.
• Proactively engage in training and development cross-functionally to improve the expertise of the organization to fulfil regulatory requirements.
• Advise organization on regulatory requirements related to personal protective equipment, environmental & chemical regulations, and similar related standards in the region and relevant to the Hoya Vision Care portfolio.

The following are the key stakeholders for this position: Regulatory affairs, quality, research and development, clinical and medical affairs, marketing, supply chain, commercial, operations, legal and compliance departments.

• Education:
  • Bachelor's degree in a scientific field, preferably in engineering, life-sciences, or regulatory discipline.
  • Master’s degree in a scientific or regulatory field preferred
• Experience
  • 6-8 years of Regulatory Affairs experience in the Medical Device industry, preferably in the ophthalmic industry.
  • 3 years of managerial experience.
  • Demonstrated ability to lead and author FDA pre-submissions, 510(k)s and product approvals for medical devices, and experience of submission requirements in the Canada and LATAM markets. Preferably experience in obtaining FDA clearance for a novel medical device.
  • Previous interactions with the FDA, Health Canada and LATAM regulatory agencies, and experience of networking and lobbying external agencies.
  • Demonstrated experience regarding Quality Management System activities compliant with ISO 13485 and 21 CFR 820.
• Hard skills
  • Extensive knowledge of ISO 13485 and ISO 14971, and 21 CFR 820.
  • Knowledge of US FDA medical device regulations, MDSAP, Canadian MDR, and ANVISA and other international requirements.
  • Good project management and change management skills focused on Regulatory Compliance, Process improvement, etc.
• Behavioral attributes
  • Must be a hands-on team contributor.
  • Ability to communicate clearly and work collaboratively with other departments/teams located around the world.
  • Excellent organizational skills and attention to detail.
  • Excellent English verbal and written communication skills.
  • Flexibility to accommodate working with international colleagues.
• Mobility: willingness to travel occasionally (<10% of the time), both domestically and internationally