Are you an experienced regulatory affairs expert looking for an exciting opportunity to lead strategic initiatives and ensure compliance in the medical device industry? Join our team as a Senior Regulatory Affairs professional and play a vital role in shaping our regulatory approach, driving product compliance, and achieving market success.
About Us
We are a dynamic organization committed to innovation and excellence in the medical device industry. Our mission is to develop groundbreaking products that meet the highest industry standards and improve lives. As part of our team, you’ll enjoy a supportive and collaborative work environment with ample opportunities for growth.
Responsibilities
What to Expect Day-to-Day
As a Senior Regulatory Affairs professional, your role will include:
- Preparing and updating technical documentation in compliance with EU MDR and 510(k) regulatory requirements.
- Developing and maintaining risk management and usability evaluations following ISO 14971 and IEC 62366-1 standards.
- Reviewing and ensuring compliance of labeling, IFUs (Instructions for Use), surgical techniques, and promotional materials.
- Updating divisional SOPs and recommending timely changes to align with regulatory compliance.
- Leading document compilation for submissions, license renewals, and annual registrations.
- Applying expertise in regulatory frameworks and maintaining compliance with processes and procedures.
- Monitoring and enhancing regulatory task tracking systems for efficiency.
- Identifying and implementing changes in regulations, standards, and guidance to maintain product compliance.
- Coordinating with internal teams, Notified Bodies, distributors, suppliers, and other regulatory authorities.
- Preparing for external audits/inspections and communicating with external auditors/inspectors.
- Training clients and staff on regulatory compliance and quality management system requirements.
- Participating in New Product Development teams to provide regulatory guidance and ensure global compliance.
- Offering ongoing regulatory advice during product and process development.
- Researching vigilance databases for adverse events and recalls.
Qualifications
What You Bring to the Table
We are seeking a candidate with:
- A Bachelor’s degree in science, medical, or a technical field.
- Minimum of 4+ years of progressive experience in medical device regulatory affairs.
- Strong knowledge of EUMDR, USFDA, ISO 13485, and other relevant standards.
- Proven regulatory experience, preferably in the medical device industry.
- Exceptional computer skills, including proficiency in Excel, Word, and PowerPoint.
- The ability to work efficiently and independently with focused attention to detail.
- Strong cross-functional communication skills, both written and verbal.
Skills
What Makes You a Great Fit
- Demonstrated expertise in regulatory compliance and quality management.
- Excellent organizational and time management skills.
- Capability to analyze complex regulatory requirements and implement practical solutions.
- Strong interpersonal skills for collaboration with internal and external stakeholders.
Send Your Resume On hr@bonetechmedisys.com
