Senior Regulatory Affairs Specialist

Description It is MEDRAD's mission to be a worldwide market leader of medical devices and services that enable or enhance diagnostic and therapeutic imaging procedures. MEDRAD performance is a result of an unrelenting commitment to improving healthcare, to upholding standards of excellence, and to responsible activities for the benefit of our customers, shareholders, employees, and communities. These values are expressed through our culture and philosophy, as well as our ethical and corporate responsibility policies. MEDRAD has over 1, 8 00 global employees, 1,200 of whom are in the Pittsburgh area. MEDRAD's European headquarters office is located in Maastricht, The Netherlands. Our Asian headquarters office is in Osaka, Japan with additional international offices located in France, Germany, Italy, China, UK, Brazil, Norway, Belgium, Sweden, Denmark, Singapore, Egypt, Mexico, Cyprus and Australia.

The Senior Regulatory Affairs Specialist develops and executes regulatory strategies for obtaining expedient marketing clearance and maintaining that clearance in the United States, European Union and throughout the world. Assures compliance to the company Quality System and all applicable domestic and international regulations and standards. Additional responsibilities include:

1. Develops and implements appropriate strategies for obtaining U.S. and International regulatory approvals for Possis products.
a. Obtains and reviews Marketing Plan by country, desired indication for use, expected timeline, and other project requirements from the Product Development team.
b. Researches possible strategies for legal market access and recommends appropriate regulatory pathway to Product Development teams.
c. Provides product development teams with guidance on appropriate testing and documentation to obtain and maintain regulatory approvals.
d. Alert organization to relevant regulatory risks.

2. Coordinates and prepares of US/European/Asian/Americas and other regulatory submissions, including IDE, PMA, PMA supplements, 501(k), Technical Files, Design Dossiers.
a. Obtains and reviews facts and information from various departments within the organization and external sources.
b. Organize, summarize and submit required documentation to FDA or International regulatory bodies/distributors.

3. Monitor product changes and submit Change Notifications or submissions as needed to Notified Body, European Rep, US and International regulatory governing bodies.
a. Provides regulatory sign-off for engineering change requests, deviation authorizations, nonconforming material records, labeling, and marketing materials to determine whether the change is a significant change to a marketed product.
b. Ensures that significant changes are reviewed and approved as needed by the appropriate regulatory agencies prior to implementation.
c. Provides proactive guidance to individuals and departments who are contemplating a product change regarding whether the change will require a regulatory submission, the type(s) of submission needed, timing, and data requirements.

4. Adheres to procedures and systems to prepare and submit US and International Vigilance reports. Assists with investigations of adverse event reports, monitoring of safety reports and trends, and reporting to appropriate regulatory bodies.

5. Reviews and approves product labeling and marketing literature to ensure compliance with regulatory requirements for product promotional and educational activities. Provides training and guidance for sales and marketing personnel regarding appropriate promotional and educational activities.

6. Monitor changes to domestic and international regulations and standards and assess impact on company and provide regulatory guidance and support for clinical trials including review of protocols, submission of IDEs and reports, and assist in evaluation of results.

7. In cooperation with other departments, assists in ensuring compliance with Possis� Quality System and all applicable medical device regulations including the Medical Device Directive, Medical Devices Regulations, and the Quality Systems Regulation.

8. Performs general project and administrative activities to support assigned responsibilities.

Technical & Behavioral Requirements:

1. Bachelor�s degree in life or physical sciences, engineering, or other related field is required.

2. Five to seven years of job related experience in medical clinical affairs, regulatory, or quality affairs for drugs or medical devices is required.

3. Three years experience in medical devices regulations, plus related experience such as quality assurance, engineering clinical programs, and/or technical writing is preferred with combination device/drug product experience strongly preferred.

4. Advanced knowledge of FDA and International regulations pertaining to medical devices and combination products.

5. Analytical, interpretive and technical writing skills to apply regulations to our products.

6. Knowledge of medical terminology and anatomy and interpersonal skills to effectively communicate and interact with internal staff and external regulatory agencies and with study site personnel and physicians.

7. Intermediate skills in utilizing a variety of software programs for word processing, spreadsheet, database and presentation applications.

8. Ability research U.S. and International regulatory requirements and industry standards using government websites and other appropriate sources.

9. Ability to make independent decisions, plan and execute regulatory strategies.

10. Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion.

11. Proven ability to demonstrate at minimum, MEDRAD�s Team Contributor competencies: Action Oriented, Perseverance, Dealing with Ambiguity, Learning on the fly and Problem Solving.

Requirements Please refer to the Job Description for the qualifications.