Sr. Quality Compliance Specialist (Medical Device)

Rensselaer, New York, US
Oct 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Provide Technical Support and guidance to ensure compliance to the requirements of the medical device quality system focused on combination products for biological therapeutics developed in-house and in collaboration with partners and CMO's.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Support activities related to the Medical Device Quality Management System ensuring compliance to all applicable medical device regulations.

• Support actions required as a result of updates to standards and/or new applicable standards.

• Manage projects related compliance of the quality system, development of of new procedures and controls, and maintenance of established programs.

• Support activites related to medical device component qualification.

• Perform verification /inspection of outgoing materials for Human Factor studies.

• Perform or review First Article and incoming materials inspections of components that have been manufactured per development specifications.

• Identifies recurring events and ensures appropriate actions are taken, such as Management notification.

• Prepare data/presentatations representing current status of compliance to procedures and regulations.

• Support and contribute continuous improvement initiatives for Med Device Quality.

• Lead and manages Change Controls for QA Med Device.

• Lead and manages Deviations and Corrective and Preventive Actions for QA Med Device.

• Up to 10% travel.
Education and Experience:

• Requires a Bachelor of Science/Bachelor of Arts degree and 6 years of industry/relevant experience. May substitute work experience in lieu of degree.

*Level will be determined based on skills and related experience.*

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.