Sr. Regulatory Specialist

RadNet; Somerville (MA); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company is seeking a Senior Regulatory Specialist responsible for developing regulatory strategies for products. The role involves ensuring compliance with regulatory requirements, leading interactions with teams for product approvals, and addressing clinical risk assessments. The ideal candidate has a strong background in regulatory affairs within the medical device industry and excellent communication skills.

Qualifications

• 5+ years working in a regulated industry, preferably FDA.
• Knowledge of ISO standards and regulatory submissions.
• Experience with pre- and post-market clinical studies.

Responsibilities

• Lead regulatory approval processes for products including FDA clearance.
• Collaborate with engineering and product teams for compliance.
• Create and maintain technical documentation for regulatory approvals.

Skills

Knowledge of Medical Devices Regulations

Excellent written and oral communication skills

Regulatory compliance

Education

Bachelor’s degree or higher in relevant field

Job description

Responsibilities

Job Summary

The Senior Regulatory Specialist is responsible for creating comprehensive regulatory strategies for existing and new products, significant product changes, and post-market activities, considering global regulatory landscapes and potential risks.

Essential Duties and Responsibilities

• Plan, define and lead relevant process related to product Regulatory approval, including but not limited to, FDA clearance, and CE Marking.
• Lead the interactions and collaboration with engineering and product teams to ensure regulatory compliance for product markets.
• Provide regulatory guidance to the development teams for registration of products, including specific national requirements.
• Create and ensure maintenance of technical documentation, as required for obtaining and/or maintaining regulatory approval/clearance for the products; specifically, to support marketing and distribution of the products outside of the US.
• Plan, execute and document clinical risk assessment sessions with relevant internal and external experts.
• Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of the products and product changes.
• 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

• Bachelor’s degree or higher in relevant field (or equivalent experience).
• Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP (including Canada, Australia, and Brazil), ISO 14971, ISO 62366, IEC 82304-1, IEC 62304.
• 5+ years working in a regulated industry (FDA and Software as a Medical Device preferred).
• Knowledge and experience drafting and submitting various regulatory filings, including but not limited to, Notification of Change requests for the international market.
• Experience interacting with Regulatory Authorities.
• Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
• Excellent written and oral communication skills.

Quality Standards

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
• Follows OSHA regulations, RadNet and site protocols, policies and procedures.
• Follows HIPAA, compliance, privacy, 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 RadNet guidelines.
• Consistently adheres to the time management policies and procedures.
• Completes job responsibilities in a quality and timely manner.

Physical Demands

This position often requires sitting and standing for extensive periods of time.

Working Environment

Remote setting. This position may require domestic and/or international travel up to 25%.

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

Job Summary

The Senior Regulatory Specialist is responsible for creating comprehensive regulatory strategies for existing and new products, significant product changes, and post-market activities, considering global regulatory landscapes and potential risks.

Essential Duties and Responsibilities

• Plan, define and lead relevant process related to product Regulatory approval, including but not limited to, FDA clearance, and CE Marking.
• Lead the interactions and collaboration with engineering and product teams to ensure regulatory compliance for product markets.
• Provide regulatory guidance to the development teams for registration of products, including specific national requirements.
• Create and ensure maintenance of technical documentation, as required for obtaining and/or maintaining regulatory approval/clearance for the products; specifically, to support marketing and distribution of the products outside of the US.
• Plan, execute and document clinical risk assessment sessions with relevant internal and external experts.
• Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of the products and product changes.
• 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

• Bachelor’s degree or higher in relevant field (or equivalent experience).
• Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP (including Canada, Australia, and Brazil), ISO 14971, ISO 62366, IEC 82304-1, IEC 62304.
• 5+ years working in a regulated industry (FDA and Software as a Medical Device preferred).
• Knowledge and experience drafting and submitting various regulatory filings, including but not limited to, Notification of Change requests for the international market.
• Experience interacting with Regulatory Authorities.
• Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
• Excellent written and oral communication skills.

Quality Standards

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
• Follows OSHA regulations, RadNet and site protocols, policies and procedures.
• Follows HIPAA, compliance, privacy, 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 RadNet guidelines.
• Consistently adheres to the time management policies and procedures.
• Completes job responsibilities in a quality and timely manner.

Physical Demands

This position often requires sitting and standing for extensive periods of time.

Working Environment

Remote setting. This position may require domestic and/or international travel up to 25%.

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