Weavr Health has been named as one of Boston's Best Small Companies to Work for in 2022 by Built In and we are looking to add a strong addition to our amazing team! As a company, we have developed a revolutionary product for the collection and dry storage of human patient blood samples. We are looking for a Senior Manager of Quality & Regulatory Affairs to develop and deploy a quality and regulatory strategic plan that strengthens the organization's quality leadership position in the industry and prepares the organization to meet the challenge of continued growth. We have a strong existing team with excellence in engineering, usability, and quality systems. Our top priority, as a company and as individuals, is a commitment to integrity across all interactions, internal and external.
The Senior Manager of Quality & Regulatory Affairs will be responsible for reviewing, directing, and managing quality and regulatory strategies, organization, and execution ensuring that approaches are innovative, industry-leading, and meeting the needs of customers and the business. The person who joins our team in this role will act as an expert consultant and mentor to employees and other functional groups on quality and regulatory matters.
The ideal candidate enjoys solving complex problems, works effectively with cross-functional teams and thrives in a fast-paced setting that is constantly evolving. They should be a self-starter with demonstrated ability to think strategically and analytically about business, product, and technical challenges. They will leverage their extensive experience and working knowledge of quality and regulatory systems and new product development to play a key role in establishing and improving capabilities to develop and launch new products that are of the highest quality and compliant to medical device regulations. Weavr Health values authentic, strong-willed individuals who think creatively, and will proactively seek out opportunities to advance the growth initiatives of our business.
Job duties include:

• Act as the Management Representative for the Quality Management System
• Perform design assurance activities such as independent reviewer or design assurance engineer for new products
• Secure U.S. and global regulatory authorization for new products, product updates and product expansions including the preparation and filing of submissions, responding to regulatory authorities and auditors, and leading meetings with regulatory authorities

• Formulate regulatory strategies for pipeline products
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop strategies for resolution
• Oversee processes involved with maintaining annual licenses, registrations and listings
• Oversee advertising and promotional review to ensure regulatory compliance
• Serve as the internal go-to subject matter expert on regulatory matters. This includes providing regulatory advice and oversight to other functional areas
• Represent the company in external meetings on regulatory matters, including with regulators and auditors, development partners, scientific and clinical advisors, and the investment community

• Oversee and support the Quality Management team, including in quality management systems implementation, regulatory authority inspections, post-market surveillance, complaint handling, CAPAs and product recalls, and all other relevant compliance obligations
• Ensure company is regulatory inspection ready at all times (FDA, Notified Body, international regulatory bodies, customers)
• Direct investigations and implement corrective actions to resolve complaints and non-compliance instances

Experience:

• 1-3 years of regulatory compliance/quality systems/regulatory submissions experience in medical devices required
• 1-3 years' experience as a Manager
• Record of successful IVD, Medical Device filings, including 510(k) or EUAs.
• Prior experience with international medical device regulatory requirements and marketing authorization
• Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others

• Extensive knowledge of ISO 13485, QSR and CE marking
• Demonstrated ability to effectively manage multiple priorities in a fast-paced deadline-driven environment

Education:

• Bachelor's Degree required, preferred in life sciences, health care, or related discipline

Benefits:

• Competitive pay, stock options, and annual bonus eligibility

• Option to participate in company medical, dental, and vision plans
• Commuter benefits
• Conveniently located close to the Alewife MBTA station
• Company-paid parking spot
• Weekly catered lunch

• 401(k) retirement plan options
• Ongoing professional development
• Secure / Covered Bike Storage Facility
• Office park amenities such as a fitness center, community events, outdoor recreation events, Pop-up Shops, and Tenant Appreciation Events

Weavr Health is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. We celebrate diversity and are committed to creating an inclusive environment for all employees.