CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our team and therefore looking for a Regulatory Affairs FDA Compliance Manager.
- Plan and implement regulatory compliance training activities for company employees.
- Review and write relevant standard operation procedures (SOPs). Assist with the design, update, and adherence to standard operating procedures to meet regulatory standards.
- Develop regulatory strategies to support PMA and 510k processes. Support RD and CT department in the compilation of the technical dossiers and their submissions to the agency.
- Prepare regulatory documents required for timely completion of regulatory submissions that include some or all of the following: pre-submissions, PMA, 510(k), IDE.
- Provide regulatory guidance to the company throughout the product life cycle, assess variations and file amendments with the agency to keep PMA and 510k dossiers up to date as basis for product release. Prepare and submit yearly reporting to the agency and approval supplements. Maintain appropriate registrations and product listings.
- Detect, read, interpret new and modified regulations, guidance, standards for new and current compliance procedures and monitor their implementation.
- Specify and coordinate product and distribution related labelling requirements and regulatory release of labelling.
- Review and regulatory release of marketing material for appropriate labelling and claims: IFU, internet, audio and video media. Collaborate with appropriate departments for developing applicable materials need to gain market clearance.
- Advice marketing and distribution operations in distribution, advertising regulatory requirements in the light of product launch.
- Support post-market corrective actions in cooperation with vigilance activities.
- Provide assistance as needed with corporate regulatory compliance.
- Other duties, as assigned.
- Bachelor’s Degree - preferably in Life Sciences or Engineering disciplines
- Minimum 5 years medical device industry experience in a regulatory affairs role in the EU and FDA. Experience interfacing directly with the FDA is required.
- Experience with substance based devices and device combinations is an asset.
- Thorough understanding of medical device agency regulations: FDA’s medical device regulation (21 CFR Part 820), CE, European MDD/MDR.
- Working knowledge of applicable medical device standards. E.g.: ISO 13485, ISO 14971, ISO 10993, ISO 14630, ISO 15798, ISO 14155, others
- Experience developing successful regulatory strategies.
- Experience specifying and reviewing product labelling and marketing materials.
- Experience with regulatory compliance processes, regulation and standards implementations.
- Experience in managing PMA and 510k processes.
- Ability to identify, qualify and work with external regulatory consultants.
- Strong leadership and interpersonal communication, self-motivated with a proactive attitude and the ability to work independently, strong problem-solving and decision-making skills, strong written and oral communication skills.
- Strong organizational skills and team oriented.
- Computer proficiency (MS Teams, MS Word, Excel, PowerPoint, Outlook, SharePoint programs).
We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!
For this position, a salary of EUR 56,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.