Regulatory Affairs Specialist

Job Summary
Responsible for preparing regulatory submissions in the APAC region required to market new or modified devices including all relevant maintenance activities.


Essential Functions

• Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals for the APAC region- such as CFDA/TFDA/HSA/MDA, CDSCO, MFDS.
• Represent regulatory affairs on project/product teams, e.g.: labelling, risk management, and design review meetings.
• Working with department management & providing regulatory guidance and guidance on applicable standards to cross-functional groups.
• Working with department management provides APAC regulatory strategies and regulatory plans.
• Working with department management, communicating with APAC regulatory authorities.
• Coordinates/prepare and maintains regulatory notifications within the APAC region.
• Coordinates/prepare and maintains APAC files in accordance with the specific in-country regulations for the APAC requirements, manages and ensures timely updates for all applicable APAC certifications.
• Coordinates and prepares responses to regulatory agencies or other such regulatory agency letters.
• Supports Reviews of product labeling changes
• Reviews promotional literature and marketing materials
• Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory 
• authorities that may impact the company.
• Participates in regulatory audits/inspections as required
• Writes SOPs and train key personnel as needed
• Comply with all policies and standards.
• Any other job responsibilities as assigned by management and subject to modification.

Required/Preferred Education and Experience

• 2-3 years of regulatory experience in the Medical Device Industry preferred
• Experience with medical device regulatory submissions with CFDA, HSA, TFDA, MDA, CDSCO, MFDS preferred
• Previous experience working with APAC Regulatory Authorities relative to premarket and compliance activities preferred.
• Experience with medical device submissions preferred.
• Degree in Regulatory Affairs or Regulatory Affairs Certification preferred

Knowledge, Skills and Abilities

• Project management skills
• Degree in RA or Regulatory Affairs Certification a plus
• Must be able to work under pressure to meet regulatory reporting time frames and company requirements
• Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
• Knowledge of U.S. and European/International regulations and standards
• Experience interacting with FDA and/or other regulatory agencies
• Must work well in team environments
• Must demonstrate leadership skills in team setting.
• Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Documented evidence of writing skills
• Basic understanding of computer applications
• Familiarity with medical terminology a plus

Travel Requirements

• 10% travel required

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.