We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits.
At Aerin Medical our values show up as: always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation and being all in.
As the Senior Regulatory Affairs Specialist, you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care.
PURPOSE OF THE JOB:
This position is responsible for maintaining Aerin quality system to meet applicable regulatory requirements and providing regulatory expertise to R&D, marketing and quality functions on regulatory standards and requirements. The job scope includes product registration, product labeling and promotional material review, change notification, regulatory reporting and compliance activities.
MAJOR DUTIES AND RESPONSIBILITIES:
- Lead the preparation and submission of product registration application/dossier for new medical devices and modifications to existing devices.
- Ensure device complies to 21 CFR 820 and EU MDR requirements
- Lead and collaborate with cross-functional team members in preparation activities for responses to regulatory authority queries.
- Communicate directly with regulatory authorities such as FDA, Health Canada, the EU Authorized Representative, Competent Authorities and/or Notified Bodies.
- Identify need for regulatory or quality processes & standardization and work closely with RA/QA leadership to solve.
- Assess regulatory impact of product/process change. Submit and obtain regulatory change notification or approval.
- Support and manage key regulatory and quality initiatives as assigned
- Support other department projects (e.g. by R&D, Sales & Marketing, Clinical) and queries, ensuring applicable regulatory related requirements are met
- Monitor, maintain and track product registration licenses and validity status
- Create and maintain device technical documentation and Declarations of Conformity.
- Prepare and submit post-market vigilance, adverse event, product field corrective action, recall, advisory notice and related documents to regulatory authorities in a timely manner
- Review and approve product label and promotional materials for compliance with applicable regulations.
- Establish and maintain procedures to fulfill country-specific regulatory requirements
- Keep abreast of changes in regulatory environment. Provide advice to management on impact of change(s) to business of such regulatory changes, where applicable
- Prepare and conduct QMS related trainings, as applicable.
- Conduct gap analysis of new and revised standards/regulations
- Drive/support readiness of internal/external regulatory body audits/inspection
- Drive resolution and closure of audit findings and/or inspection findings, if any
- Keep abreast of changes in regulatory environment. Provide advice to management on impact of change(s) to business of such regulatory changes, where applicable
EDUCATION REQUIREMENTS:
- Bachelor’s degree or diploma preferably in a Scientific, Engineering or similar discipline
EXPERIENCE REQUIREMENTS:
- At least 3 or more years of experience in regulatory affairs and/or quality management systems in medical device industry is required
- Good understanding of ISO 13485, EU MDD/MDR, FDA QSR 21 CFR Part 820, and ISO 14971 is required.
- Must have hands-on registration experience with FDA 510(k), and EU MDR product submissions. Experience with MDSAP is advantageous.
- Experience in promotional material review is beneficial.
- Prior working experience in a manufacturing and/or device design authority environment preferred.
- Experience with single-use sterile devices, biological safety, devices containing software, cybersecurity requirements is desired.
OTHER QUALIFICATIONS:
- Self-motivator with strong sense of ownership on assigned responsibility
- Capable of driving results through others
- Proactive with resilient drive towards achieving department and organization’s goals
- Resourceful and possess good problem-solving skills
- Demonstrated ability to work collaboratively with cross-functional departments and stakeholders in a constructive manner
- Ability to view issues from a broad and detailed perspective
- Excellent interpersonal and communication skills (both verbal and written) and capable of effective communication with all levels of organization
BENEFITS AND PERKS:
Our culture is rooted in our core values every day, in everything we do.
Our benefits focus on the 5 dimensions of wellbeing: physical, financial, emotional, career and community. Physical benefits include Medical – PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. Financial benefits include HSA/FSA, 401k with company match, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). Career and Learning & Development opportunities with Aerin led leadership trainings. Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving.