Regulatory Affairs Specialist, International
- Marlborough, MA
- $72,100-112,800 per year
- Permanent
- Full-time
- Prepare and compile document packages for regulatory submissions, audits, and inspections for both domestic and international markets.
- Maintain regulatory databases and technical files to support global product registrations.
- Review labeling, marketing materials, and user manuals for compliance with US and international regulatory requirements.
- Identify and recommend changes for labeling, manufacturing, marketing, and clinical protocols.
- Participate in design reviews and develop regulatory strategies for product approvals in multiple geographies.
- Support cross-functional teams and process improvement initiatives, collaborating with global colleagues.
- Stay current with existing and emerging regulations, standards, and laws in all markets where we operate.
- Strong written, verbal, and interpersonal communication skills.
- High attention to detail and accuracy in documentation.
- Excellent technology proficiency (MS Office, document storage systems).
- Knowledge of ISO 13485, ISO 9001, FDA, and foreign (EU, Canada, etc.) regulatory requirements.
- Understanding of data/statistical analysis.
- Regulatory Affairs Certification (RAC) and project management experience a plus.
- Analytical thinking and sound judgment within defined procedures.
- Collaborative mindset-works productively across internal and external, global teams.
- Proactive approach to identifying and resolving compliance issues.
- Commitment to continuous learning and professional development.
- Bachelor's degree in a technical field preferred.
- 2-5 years' experience in regulatory affairs (medical device industry).
- Experience with technical documentation and regulatory databases.
- Primarily office-based work (sitting, computer use).
- Limited travel as necessary (up to 10%)