Director of Regulatory Affairs and Quality Assurance - Full Time
Location: Guilford, ME
Puritan Medical Products is hiring a Director of Regulatory Affairs and Quality Assurance to join their team saving the world, one swab at a time. This role will support locations in Guilford,Maine. Join Puritan in the quest to get testing supplies to the professionals!
A family-owned business for over 100 years, Puritan offers a comprehensive benefits plan, the opportunity to advance, and a warm and friendly employee-centric atmosphere. Benefits are available to employees working 32 hours per week and include medical, dental, and vision insurance, as well as employee and dependent term life insurance.
We are looking for candidates who bring a cooperative spirit, welcome the opportunity to learn, and take pride in a job well done.
The Director of Regulatory Affairs and Quality Assurance has direct responsibility for managing the Regulatory Affairs Department. This role enables the business objectives of the company by implementing and managing regulatory affairs activities and establishes processes that ensure timely product registrations, product availability, and post market support that satisfies customer requirements.
- Ensures the establishment and maintenance of regulatory affairs processes for U.S. registrations and product development, international registrations, and post market – sustaining activities, including:
- Monitoring new and changing regulations and guidance and disseminating information to stakeholders.
- Identification of regulatory trends and provision of key regulatory intelligence updates on a global basis.
- Preparation of documentation for international and domestic product registrations for new and modified products.
- Evaluation of information to develop strategies and shape future regulations and guidance, as well as interact with governmental regulatory agencies, other third-party accrediting bodies, and US trade associations.
- Represents company on US trade associations and contributes to trade positions.
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally.
- Researches scientific and regulatory information to write, edit, and review submission documents.
- Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Works with governmental regulatory agencies and other third-party accrediting bodies.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Adds and maintains information contained in the Global Regulatory Information Database.
- Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
- Reviews validation reports for regulatory submission soundness.
- Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.
- Reviews advertising and promotion to ensure compliance with product claims.
- Ensures consistent guidance and interpretation of regulations, standards, and regulatory intelligence for application to design and development planning, registration planning, and impact assessments.
- Provides leadership and management of the department.
- Engages with company quality leads and other division regulatory affairs leads to align on and establish policy.
- Establishes and manages the department budget.
- Ensures continuous improvement in alignment with industry best practices
- Reports on department metrics to senior leadership.
- Contributes to management review for new or revised regulations and/or other quality system activities.
- Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
- Carries out duties in compliance with established business policies.
- Act as Person Responsible for Regulatory Compliance (PRRC) regarding
- Ensuring the technical documentation and the EU declaration of conformities are drawn up and kept up to date.
- Ensuring in the case of investigational devices, a signed statement that the device conforms to the general safety and performance requirements according to IVDR is issued.
- Other duties as assigned, according to the changing needs of the business.
- Bachelor's degree (BS/BA) in any biological science
- Minimum of 10 years of experience in Regulatory Affairs, US and international
- Minimum of 5 years in an IVD or medical device manufacturing environment
- Must be knowledgeable of federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDR, MDR, FDA, MDSAP, ISO 11135, ISO 11137, ISO 15223-1 AND -2, ISO 14971, ISO 19011, ISO 10993-1 AND -7 AND -10, ISO 11607-1 AND A1, 93/42/EEC, EN 556-1/AC, IVD 98/79/EC.
- International regulations experience
- Strong knowledge of international regulations
- Strong knowledge of quality systems in a regulated manufacturing environment
- Good knowledge of business models, resource planning and budgeting
- Ability to work with staff at all levels of organization, global teams including time-zone flexibility
- Excellent presentation, oral and written communication skills, computer skills with MS Office applications
- Skilled in using computers, specifically MS Word, Power point, Excel
- Process orientated, detailed, logical, analytical, meticulous and highly organized, able to analyze data and implement solutions
- Adaptable and willing to take on multiple new tasks and responsibilities while managing and prioritizing multiple tasks within a dynamic work environment
- Strong management skills with proven leadership and team building skills
NO PHONE CALLS OR RECRUITERS PLEASE
Puritan Medical Products is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, credit history, unemployment status, or veteran status.
KMA Human Resources Consulting is a Maine-based company that handles recruiting and human resources for its clients. They are working with Puritan to hire the future workforce that will be manufacturing swabs at both our Guilford and Pittsfield locations. KMA is proud to partner with Puritan to provide full-service recruiting support during this period of fast growth at Puritan. Applications for both Guilford and Pittsfield positions will be reviewed by KMA and they will work closely with Puritan to move candidates through the interview process.