Senior Regulatory Affairs Specialist
Participate in product development core teams to provide necessary regulatory guidance and deliverables to ensure successful registrations in the US and abroad.
· Assist with preparing document packages for regulatory submissions, including Q-Submissions, 510(k)s, and international product registrations.
· Work cross-functionally to prepare and maintain documentation compliant with EU IVDR.
· Support EU representatives in their creation of CE/IVD Technical Files.
· Provide regulatory review of labeling and promotional materials.
· Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
· Provide regulatory review of customer complaints and file vigilance reports, as appropriate.
· Communicate planned changes in the regulatory landscape and provide strategies to maintain compliance.
· Assist with the administration of regulatory and third-party audits.
· Responsible for maintaining internal regulatory file documentation.
Bachelor’s degree in Life Sciences or related discipline required. Advanced degree preferred. Professional certification(s) a plus.
· Minimum of 5+ years of experience in Regulatory Affairs within the Medical Device and/or Medical IVD industry required, ideally within a small, rapidly growing organization.
· Knowledge of FDA and ISO regulations and standards required.
· Must have experience interfacing with the FDA (e.g., Pre-Submission meetings, 510(k), De Novo, and/or PMA submissions).
· Must have familiarity with International documentation and working with Notified Body and Authorized Representatives.
· Familiarity with scientific, clinical, quality and process development aspects of product development strongly preferred.
· Knowledge of design controls and excellent written and verbal communication skills.
· Ability to work effectively cross functionally to meet objectives.
· Must have a positive attitude and a proactive, collaborative approach to problem solving.
It is the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population.