Sr. Regulatory Specialist Position Available In Middlesex, Massachusetts

Sr. Regulatory Specialist
Artificial Intelligence
12358
212 Elm Street 4th Floor, Somerville, Massachusetts, US, 02143
Full-Time
Remote
USD $130,000.00/Yr.
USD $140,000.00/Yr.
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Job Description
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. We are a Equal Employment Opportunity employer. Our policy is to provide equal employment opportunities to all applicants and employees without regard to race, religion, creed, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by applicable law. If you need a reasonable accommodation for any part of the employment process (including the application, any testing, or interview process), please contact us by email at Talent Acquisition Department and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. We encourage all qualified individuals to apply for employment. We consider for employment qualified applicants with criminal histories, or arrest or conviction records, in a manner consistent with relevant legal requirements, including the City of Los Angeles’ Fair Chance Initiative For Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, the San Francisco Fair Chance Ordinance, California Fair Chance Act, and the New York City Fair Chance Act, where applicable. The salary of the candidate selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty, location, and training. Any listed pay scale is not a guarantee of a particular wage.