SENIOR REGULATORY AFFAIRS ASSOCIATE Pioneer Surgical Technology
THIS JOB HAS EXPIRED Job Purpose Summary: This position supports continued professional growth in Regulatory Affairs (RA). A strong understanding of US medical device regulations throughout the product lifecycle is required. This position includes involvement in international/multinational regulatory issues as well as concepts of regulatory strategy. This position is actively involved in technical and scientific regulatory activities, as well as regulatory systems development.
Supervision Received and Exercised: This position reports to the Director of Regulatory/Clinical Affairs.
Responsible for management, preparation and maintenance of both U.S. and international regulatory submissions/premarket filings and registrations to acquire appropriate market clearance in an expeditious/efficient manner.
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Support ensuring that RA system activities are in place and are conducted in accordance with applicable regulations and standards including, but not limited to, U.S. FDA Quality System Regulations, ISO (International Organization for Standardization) Standards, and the European MDD (Medical Device Directive).
Monitor impact of changing regulations and standards, and participate in systems development to ensure continued compliance.
Control and maintain regulatory records.
Provide regulatory support throughout the product lifecycle. Represent Regulatory Affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs. Review and approve new documents and product changes for compliance, and to determine if a new premarket application is required.
Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to medical devices including, 510(k)s, labeling and promotional materials, MDD 93/42/EEC, 21 CFR 820, 801, global registration, technical writing, etc.
Provide training both in and outside the department.
Strong knowledge of current US FDA Quality System Requirements (QSR), and ISO 13485, foreign directive and regulations
Experience with orthopedic or spinal implants preferred.
Strong analytical, research and problem solving skills
Ability to write and edit technical documents
Must be detail oriented & highly organized
Ability to work independently and exercise judgment with limited supervision
Must possess strong interpersonal communication skills.
Ability to prioritize workload with limited supervision
Must demonstrate teamwork building skills in & outside department.
Ability to exercise judgment
Computer and internet proficient
Occasional travel (5-10%)
Education and Training Requirements:
Bachelors degree required. Engineering, medical, or science related field preferred.
Seven (7) years of medical device industry experience, with at least 3 years of direct Regulatory Affairs experience.
Experience with 510(k) submission process and/or International device registrations.
Working Conditions: Office environment; exposure to computer screens
Essential and marginal functions may require maintaining physical condition necessary for sitting/standing for prolonged periods of time.
||375 River Park Circle |
Marquette, MI 49855
THIS JOB HAS EXPIRED