Overview
Role Summary: The Regulatory Affairs Manager II leads the company’s post‑market regulatory program to ensure global compliance for commercialized IL-labeled medical devices and manages a team of regulatory professionals in this endeavor. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program. The manager also develops people, builds processes, and represents Regulatory Affairs during management reviews, external and internal inspections and audits.
Responsibilities
- Lead, coach, and develop a team of post-market regulatory professionals (set goals, conduct routine performance reviews, create development plans).
- Allocate resources and prioritize workload across markets/products for post-market regulatory activities.
- Monitor/trend staff performance; drive operational excellence.
- Represent the RA Bedford function internally and externally; cultivate professional relationships with regulatory agencies and industry groups.
- Lead team in assessing and documenting regulatory impact of design, labeling, and manufacturing changes to on-market devices.
- Lead team to develop and maintain a state-of-the-art Post-Market Surveillance (PMS) program that meets worldwide regulatory requirements.
- Lead team in the timely completion of PMS Plans/Reports per IVDR and worldwide regulatory requirements.
- Lead team compliance with FDA adverse event reporting (e.g., 21 CFR Part – Medical Device Reporting) and other world vigilance reporting requirements.
- Lead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. Directly interfaces with US FDA and Health Canada customer base and regulatory agencies and supports international country affiliates and country dealers in meeting their country regulations and timelines.
- Review and approve labeling, advertising, and promotional materials for compliance; partner with RA Pre-Market/QA/Legal/Marketing to ensure alignment with labeled product claims and intended use.
- Support and lead inspections by external agencies (e.g., FDA, BSI) for areas managed, ie., vigilance, product corrections and removals, post-market surveillance, assessment of on-market product modifications.
- Monitor evolving global regulations, brief leadership and product teams on changes, impacts, and mitigation plans impacting regulatory post-market compliance.
- Participates, as the regulatory representative, in the risk analysis reviews for on-market device deficiencies to ensure the timely identification of potential reportable incidents and field corrections/removals.
- Identify compliance gaps and opportunities for improvements and assist the Senior Manager with updates to procedures and work instructions
- Support the Senior Manager as needed.
Qualifications
- Requires a Bachelor degree, preferably in regulatory or science related areas
- Minimum of 5 years of management experience in the medical device or IVD industry
- Experience with US FDA and Health Canada adverse event and field correction/removal regulations and guidelines required, with experience in international adverse event reporting and field correction/removal actions a major plus
- Experience in managing a post-market program preferred
- Knowledge of FDA 21 CFR , , , Health Canada Medical Device Regulation, European IVD Directive 98/79/EC and European IVD Regulation (EU) /, MDSAP Companion Document and ISO , preferred
Additional Information
- International Mobility: Not required
- Travel Requirements: Some travel required up to 15%
The annual base salary range for this role is currently $-$K + 10% Annual Bonus Target. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.
We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 7, employees around the world comprise our Werfen
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