Responsibilities

Job Summary

The Senior Regulatory Affairs Associate is responsible for supporting and maintaining DeepHealth’s global product submissions and corporate registrations. 

 

Essential Duties and Responsibilities 

• Actively liaise and closely collaborate with global regulatory bodies to support product market entry and maintenance.
• Identify current and new regulatory submission and market entry requirements, providing guidance to the product teams for registration of products.
• Actively manage and maintain the product distribution process to ensure only released product, medical and non-medical, is put on the market.
• Identify and implement tools and/or processes to improve the product distribution and communication process.
• Enforce compliance to applicable standards and escalate to appropriate authorities if needed.

 

PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above.  Other functions may be assigned and management retains the right to add or change duties at any time.

 

Minimum Qualifications, Education and Experience

Qualifications include:

• Bachelor’s degree in relevant field (or equivalent experience) required.
• 2+ years of experience working in a regulated industry required.
• Experience with the FDA and Software as a Medical Device preferred.
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• Knowledge and experience submitting global regulatory filings, including but not limited to, North America, APAC, and EMEA regions.
• Experience interacting with US and OUS Regulatory Authorities.
• Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
• Excellent written and oral communication skills

 

Quality Standards

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, regional and country laws concerning employment.
• Follows all DeepHealth policies and procedures.
• Follows data privacy, compliance, safety and confidentiality standards at all times.
• Practices universal safety precautions.
• Promotes good public relations on the phone and in person.
• Adapts and is willing to learn new tasks, methods, and systems.
• Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with DeepHealth guidelines.
• Completes job responsibilities in a quality and timely manner.

 

Physical Demands

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally.

 

Working Environment

Remote

 

Accommodations

Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.