Regulatory Affairs Senior Specialist (H/F)

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

RESPONSIBILITIES

PRODUCT REGISTRATIONS

• Plan, coordinate and maintain the registrations in accordance with the objectives defined by the Top Management and the EMEA Business Division; to obtain approvals on time
• Prepare / write / update submission files to obtain UE / EMEA certificate of market access (CE mark, UKCA, Swiss regulation, Egypt, Saudi Arabia, Morocco, Algeria…).
• Manage the back and forth with the National Competent Authorities and Notified Bodies, including activities as the UK, Switzerland and EU Authorized Representative and Importer (MDD 93/42 or MDR 2017/745).
• Secure the regulatory conformity of the EMEA Sales entities.
• Maintain up to date registration indicator in the EMEA.
• Do an evaluation of changes done for a product and its manufacturing process to indicate regulatory impacts.

SUPPORT THE BUSINESS DIVISIONS AND THE MARKET ACCESS

• Represent the EMEA RA team in projects launched by the EMEA Sales and/or Marketing teams to support the business development in EMEA countries
• Support the tender team as the point of contact for regulatory matters.
• Support various department to assure market access in compliance with EMEA local regulations (Distributor Agreement Letters (DAL) validation, support tender’s answers and reimbursement obtainment, shipping of products…).
• Review and approve the promotional materials issued by the EMEA Marketing team in compliance with the EMEA local regulations (i.e., Bertrand’s Law) and the INTEGRA’s rules.
• Make an active Regulatory Intelligence on the EMEA countries regulations and specific topics defined by EMEA RA Manager and the VP RA International.
• Escalate in a timely manner issues to the direction to find resolutions.

GENERAL

• Ensure the spreading of appropriated knowledge and regulatory requirements, by the mean of training of other departments.
• Ensure continuous reports to their direction.
• Support project assigned by the direction.

QUALIFICATIONS / EXPERIENCE 
•    Knowledge on the Middle East and Africa Regulations, European Medical Devices Directives 93/42/EEC, UK-MDR 2002, UKCA, MedDO, the European Medical Devices Regulation 2017/745, and their relatives; as well as the 21 CFR part 820
•    Project Management Skills
•    Experience in International and/or European products’ registrations
•    Pharmacist / Sciences Doctorate / Biomedical Engineer / Master in Regulatory or Quality
•    5 years experiences in Regulatory Affairs in Pharmaceutical or Medical Devices Industry 
•    Organizational skills, autonomous, writing skills, interpersonal skills, efficient communication

•    Languages: English Fluent

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.