Senior Regulatory Affairs Specialist

Hyperfine•Guilford, CT

6h•Hybrid

About The Position

The Senior Regulatory Affairs Specialist advises regulatory strategy for the company’s devices and ensures compliance to Regulatory requirements for the regions assigned (domestic/international). They provide expertise in translating complex regulatory requirements into practical, workable plans, as well as interacts with regulatory agencies and with senior leadership to influence company decisions. The individual in this role will also represents Regulatory for product development and is responsible for ensuring regulatory submissions and registrations are authored and submitted to targeted business project timelines. They will be responsible for ensuring internal and external compliance is aligned to stated practices and procedures and supports regulatory and agency inspections and/or audits as necessary. They also assess and advise on regulatory strategy to the organization and design teams; including development of global regulatory strategies product change evaluations impacting regulatory filings worldwide.

Requirements

History of successful regulatory clearances/approvals in global markets.
Thorough working knowledge of Quality System standards and regulations including but not limited to 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR, UKCA.
Thorough working knowledge of risk management and other standards including but not limited to ISO 14971, IEC 60601, and IEC 62304.
Extensive knowledge of regulatory strategy and approval approaches.
Strong knowledge of medical device labeling requirements.
Effective written and oral communication skills including the ability to interact with all levels of the company.
Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures, and regulations.
Ability to navigate effectively through the regulatory process as part of a team ensuring project and company success.
Detail-oriented, hands-on, proactive problem solver.
Ability to work with minimal supervision.
Bachelor’s degree in a scientific or regulatory discipline, plus 8 years' experience in the medical device industry; or equivalent work experience.
Minimum 5 years' experience in Regulatory Affairs role.
Experience interpreting FDA and international guidelines and regulations.
History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators.
Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions.
Experience with international registrations.
Proven track record of navigating swiftly and efficiently through the regulatory process as part of a team ensuring project and company success.
Extensive experience interpreting FDA and international regulatory guidelines, understating regulatory strategy and approval approaches, working directly and interacting with regulatory agencies.
Experience hosting audits.

Nice To Haves

Experience in Research & Development (R&D).
Familiarity with AI-based software, medical imaging, active devices.

Responsibilities

Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Determine requirements and options for regulatory submissions, approval pathways, and compliance activities.
Develop global regulatory strategies and update based on changes in the regulatory landscape.
Ensure regulatory strategy outputs are properly communicated to development teams and leadership.
Lead the preparation of all necessary regulatory submissions (as assigned), in compliance with applicable regulatory requirements.
Communicate and interact with regulatory authorities before and during the development and review of a regulatory submissions; Monitor the progress of the regulatory agency review process via appropriate communication with the agency.
Develop and implement regulatory infrastructure for product versions/releases ensuring compliance with internal and global regulatory requirements.
Guide, review, and approve external communications and promotional materials to ensure accurate and compliant corporate messaging.
Evaluate the regulatory environment and provide internal advice throughout the product life cycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Act as core RA team member on development teams to provide input on design controls and regulatory deliverables; Provide guidance to teams on complex regulatory issues, including review of scientific/engineering material (protocols/reports), interpretation of standards, regulations, and guidance documents.
Ensure regulatory submissions are authored according to applicable requirements and guidelines (as assigned) including, but not limited to:
US FDA 510(k) submissions.
US FDA Pre-submissions (Q-subs).
EU MDR Submissions.
UK Submissions.
Health Canada submissions.
Australia TGA submissions.
International registrations, renewals, and amendments.
Periodic reporting to regulatory agencies as required.
Maintain US FDA establishment registrations and device listing per applicable regulatory requirements (as assigned).
Maintain GS1 account and US FDA GUIDID entries per applicable regulatory requirements (as assigned).
Review and approve engineering change orders for product modifications (as assigned).
Review and assess impact of new regulations/guidance documents applicable to the company.
Train stakeholders on current and new regulatory requirements to ensure company-wide compliance.
Act as RA lead in external audits (FDA, MDSAP, EU MDR, UKCA, etc) to meet applicable regulatory requirements and maintain QMS certifications.
Support in recruiting, hiring, and training regulatory team members.