Regulatory Affairs Manager

Location: Ballina
Department: Regulatory

The Regulatory Affairs Manager is an experienced individual contributor responsible for developing, executing, and maintaining global regulatory strategies to support the timely commercialization and continued compliance of medical device products. The role partners closely with cross functional stakeholders to ensure products meet applicable regulatory, quality, and safety requirements across global markets.

This role serves as a subject matter expert in global regulatory requirements, including U.S., EU, and international regulations such as EU MDR and FDA requirements. The Regulatory Affairs Manager provides regulatory guidance across the product lifecycle, and may act as or support the Person Responsible for Regulatory Compliance (PRRC) or the EU Authorized Representative (AR), where assigned or based on location. The position promotes regulatory excellence through education, collaboration, and continuous improvement.

• Develop and implement global regulatory strategies and associated activities to support new product development, product lifecycle management, and global market access.
• Lead, prepare, review, and support regulatory submissions, registrations, renewals, and regulatory change notifications globally.
• Assess the regulatory impact of product, labeling, manufacturing, system, and data changes and secure timely regulatory approvals.
• Serve as a regulatory subject matter expert, providing interpretation of applicable regulations, standards, and guidance documents, possessing a deep understanding of medical device regulations, including but not limited to:

• US: 21 CFR Part 820
• Canada: Medical Device Regulations SOR/
• EU: Medical Device Directive 93/42/EEC and Medical Device Regulations (2017/745)
• Brazil: Classification and Registration Requirements of Medical Product RDC 185/2001 and GMP Requirements for Medical Devices and IVDs RDC 665/2022
• Japan: Pharmaceutical and Medical Device Act (2014)
• Australia: Therapeutic Goods (Medical Devices) Regulations 2002

• Support or perform PRRC or EU AR responsibilities, ensuring technical documentation, declarations of conformity, and compliance records are maintained.
• Collaborate cross functionally with R&D, Quality, Clinical, Labeling, IT, Operations, Marketing, and external partners (e.g., distribution partners).
• Lead or support regulatory compliance projects and continuous improvement initiatives.
• Prepare and maintain regulatory documentation, reports, and compliance records.
• Review and approve labels, instructions for use, and advertisement and promotional materials.
• Support post market activities (e.g., non conformances, risk assessments, complaints) and internal and external audits (e.g., EU MDR, MDSAP, ISO 13485, ISO 14971).
• Act as a liaison with government authorities.
• Develop and deliver regulatory training and education to internal stakeholders.
• Participate in industry working groups and monitor industry best practices as appropriate.

• Communicate effectively via email, phone, and virtual platforms.
• Collaborate across departments to support organizational goals.
• Participate in cross functional meetings and initiatives.
• Prepare reports and dashboards for internal stakeholders.
• Ensure data accuracy and confidentiality in compliance with company and legal standards.
• Manage multiple priorities and deadlines in a fast paced environment.
• Lead or support special projects aligned with departmental objectives.
• Demonstrate initiative in identifying process improvements or automation opportunities.
• Serve as a point of contact for internal and external stakeholders.
• Resolve inquiries and issues with professionalism and discretion.
• Adhere to company policies, including those related to ADA, data privacy, and ethics.
• Maintain secure handling of sensitive information.
• Travel frequently, including overnight and occasional weekend travel.
• Occasional lifting of materials up to 15 pounds may be required.

• Bachelor's Degree with 8-12 years of related experience.

• Equivalent combination of education and experience may be considered.
• Regulatory credential or equivalent preferred (e.g., RAC from RAPS).
• Be Agile - innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
• Be Customer Centric - considers the needs, experiences and feedback of customers in all we do.
• Be People Focused - builds trust and collaborates with an inclusive and empathetic approach.
• Be Performance Driven - operates with an ownership mindset, driving meaningful outcomes.
• Live the Schneiders' Legacy, Our Noble Purpose - passionately serves our Mission and Vision, while demonstrating the Immutable Principles.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.