- Evaluate the regulatory environment and provide internal advice throughout the product life cycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
- 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
- Act as core team member on development teams to provide input on design controls and regulatory deliverables
- Ensure regulatory strategy outputs are properly communicated to development teams and the business
- Support product development by guiding teams on regulatory issues, including review of scientific/engineering material (protocols/reports), interpretation of standards, regulations, and guidance documents
- Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission
- Author and lead the preparation of all necessary regulatory submissions (as assigned), in compliance with applicable regulatory requirements
- Monitor the progress of the regulatory agency review process via appropriate communication with the agency
- Evaluate proposed product changes for regulatory filing solutions and propose plans for changes that do not require submissions (as applicable)
- Review and approve engineering change orders for product modifications
- Help to train stakeholders on current and new regulatory requirements to ensure company-wide compliance
- Provide regulatory input, guidance and review for proposed product claims and device labeling
- Support QMS audits to meet applicable regulatory requirements
- Influence departmental processes by implementing/updating SOPs
- Support in recruiting, hiring, and training regulatory personnel
- Other duties as assigned
- Thorough working knowledge of Quality System standards and regulations including 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR
- Thorough working knowledge of risk management and other standards including ISO 14971, IEC 60601, and IEC 62304
- Experience interpreting FDA and international guidelines and regulations
- Extensive experience in international regulatory filings
- Track record of navigating swiftly and efficiently through the regulatory process as part of a team ensuring project and company success
- Experience with medical device labeling requirements
- Detail oriented, hands-on, proactive problem solver
- Excellent written and oral communication skills including the ability to interact with all levels of the company
- Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures, and regulations
- Experience supporting audits
- Ability to work with minimal supervision
- Bachelor's degree or higher degree
- Minimum of 7 years' experience in the medical device industry
- Minimum of 3 years' experience in a Regulatory Affairs Role
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Sr. Regulatory Affairs Specialist - Guilford, United States - Hyperfine
6 days ago
Description
Company ProfileHyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point of care.
Today, eighty percent of the world's population lacks access to MRI. Hyperfine is on a mission to address the limitations of current imaging technologies and make MR imaging accessible anytime and anywhere.
Do you have a background in magnetic resonance imaging, deep learning, electrical engineering, physics, or related fields? What about health equipment sales, business development, or marketing? Hyperfine lives and works on the cutting edge of medical imaging accessibility. If you enjoy a challenge as much as you value a committed workplace, we could be the next step in your rising career.
Job Title: Senior Regulatory Affairs Specialist
Location: Boston, MA (hybrid)
SUMMARY:
The Senior Regulatory Affairs Specialist supports product development as a core team member and is responsible for regulatory submissions and registrations. The Senior Affairs Regulatory Specialist ensures internal and external compliance with stated practices and procedures and supports regulatory and agency inspections and/or audits as necessary. The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
RESPONSIBILITIES:
