180956 - EU-MDR Lead Regulatory Affairs
Industry
ENG
Region
MA-Massachusetts
City
Acton
State
MA
Rate
$73.53 to $88.24 DOE
Duration
6 months
Description

Responsibilities:
•Serve Hillrom’s Acton (MA) and Caledonia (MI) sites as the primary point of contact in all matters of European Medical Device Regulation (EU-MDR) compliance.
•Liaise with Hillrom’s global EU-MDR program network in order to leverage global efforts and standardize across sites and functional units
•Lead the Clinical Evaluation Reports (CER) workstream:
•Coordinate with Hillrom’s global CER contractor in the development of CERs
•Cooperate with other EU-MDR workstreams in preparing inputs to CERs (e.g. Technical Files, Post-Market Surveillance).
•Plan, lead & monitor workstream; regularly report progress to EU-MDR Acton & Caledonia site leads.
•Coordinate with Marketing & R&D staff to drive the development of an Advertising & Promotion Claims Matrix for products from the Acton & Caledonia sites
•Liaise with the European certifiers & Notified Bodies; ensuring continuity of EU certification for products from the Acton & Caledonia sites.
•Review remediated EU-MDR Technical Documentation, Post-Market Surveillance, Labeling & IFUs, CER (& other) deliverables & provide advice, ensuring they are developed compliant to EU-MDR requirements and consistent with Hillrom’s global standards.

Education:
Bachelor's preferred, HSD required.

Schedule:
First shift, full time.

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x307 or (800) 927-9318 x307

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.