Department: Regulatory Affairs
This position, reporting to the VP Regulatory Affairs and Quality Assurance / Health Care Compliance Officer, is responsible to perform and oversee activities related to pre-market product development, U.S and international product marketing authorization, post-market surveillance, marketing, and labeling. Responsibilities include management of regulatory information, preparation and/or coordination of global pre-market submissions for new and/or modified US Class II (EU Class I, Is, IIa, IIb) products involving durable electromechanical equipment, software, sterile single-use accessories, reusable accessories requiring reprocessing, reprocessing accessories, and procedure packs. Includes hands-on preparation and/or management of submissions to FDA, Notified Bodies, and Health Canada, and management of other product registration through OUS regulatory partners.
- Remain current with regulations, harmonized and recognized standards, Common Specifications, Implementing Regulations, and guidance for territories applicable to distribution of Gynesonics’ products. Recommend and implement procedural and technical modifications as needed to reflect changing requirements.
- Establish and maintain scalable regulatory department systems and procedures to support expanding commercial presence in the US and OUS geographies. Propose, develop, implement, and maintain department SOPs, work instructions, and forms.
- Actively manage Regulatory programs, including tracking and maintaining license, registration, and listing renewals and tracking the staging of activities and milestones in regulatory submissions.
- Act as Regulatory representative on product development and change projects. Complete or coordinate regulatory of assessment of change; prepare, review, and maintain documentation to support regulatory strategy and pathway decisions. Review and approve technical reports and data for suitability for use in regulatory submissions and audits.
- Manage, prepare, review, and submit FDA applications and other regulatory documents, including IDE’s, 510(k)s, Notified Body applications under Regulation (EU) 2017/745, state license applications, and other regulatory submissions. Communicate and negotiate with regulatory authorities. Coordinate with OUS in-country regulatory partners to obtain and maintain product registration.
- Organize, prepare, and maintain regulatory information including product Technical Documentation.
- Support assessment of reportability for vigilance and product corrections and removals.
- Manage unique device identifiers and information entries to GUDID and EUDAMED.
- Develop labeling requirements specifications; review product labeling and marketing materials for compliance with internal, national and international regulatory requirements.
- Other dues as assigned.
Knowledge, Skills, and Experience:
NOTE: Knowledge and Skill Requirements may be fulfilled with training/experience prior to hire, and/or by training provided by Gynesonics
Education Level, Required Skills and Experience:
- Bachelor degree in engineering or life science required.
- 11+ years medical device regulatory affairs experience.
- Prior experience personally writing and managing FDA 510(k), CE Mark application, and OUS submissions.
- Direct experience interacting with FDA and other regulatory agencies.
- Direct experience with audit / inspection preparation and conduct.
- Direct Quality Assurance experience including pre-clinical design control, verification and validation involving sterility, packaging, shelf and use life, biocompatibility, and software controls.
- Management and supervisory experience.
- Strong understanding of ISO 14971, ISO 13485, 21 CFR 820, and EU MDR
- Strong communication and leadership skills
- Analytical skills and detailed oriented.
- Strong technical writing skills
Gynesonics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.