Senior Regulatory Affairs Specialist - Mechelen, België - Biocartis

Biocartis

Geverifieerd bedrijf

Mechelen, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Publication date

1 December 2023

Location

Mechelen (hybrid) or UK/Europe/US East Coast (remote)

Country

Belgium
United States
United Kingdom

Workplace type

Remote

Travel percentage

0%

Department

Quality, Regulatory and Clinical Affairs

Function type

Full-time

Contract type

Employee

Experience required

Min. 5 years of experience in Regulatory Affairs;
IVD/medical device experience preferred, especially PCR or software experience
Must be able to work effectively in a strongly matrixed teamoriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts
Regulatory Affairs Certification is a plus

Education

Bachelor's degree with preference for scientific, engineering or legal studies or equivalent through experience or training

Senior Regulatory Affairs Specialist:

The Senior Regulatory Affairs Specialist is responsible for creating and executing the regulatory plans for Biocartis' diagnostic development programs and securing timely marketing authorizations according to agreed-upon plans.

The Senior Regulatory Affairs Specialist will support communications with regulatory authorities, including submissions, product registrations, and execution of any post market commitments as required.

Accountabilities

Create regulatory strategy to efficiently obtain regulatory approvals for Biocartis' products including those for Companion/Complementary Diagnostic use;
Communications with local and international authorized representatives and regulatory authorities;
Work closely with R&D teams to implement development efforts compliant to the IVDD, pending IVDR, US 21 CFR 820, and global regulatory requirements;
Work with Clinical Affairs to create clinical validation strategies to meet regulatory requirements;
Review and edit technical documentation including:
Product Validation Protocols and Reports
Software documentation
Risk Management documentation
Conduct regulatory intelligence/research to assist in formulation of regulatory plans;
Review product complaints for compliance to vigilance procedures;
Participate in periodic post market product data analysis processes; ensure postmarket reporting requirements are met;
Monitor regulatory requirements in various markets to ensure preparedness for upcoming changes;
Participate in regulatory audits/internal audits and inspections as appropriate;

Profile requirements

Bachelor's degree with preference for scientific, engineering or legal studies or equivalent through experience or training;
Min. 5 years of experience in Regulatory Affairs;
IVD/medical device experience preferred, especially PCR or software experience

;

Must be able to work effectively in a strongly matrixed teamoriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts

;

Regulatory Affairs Certification is a plus

;

Proven experience with:
Invitro diagnostics validation requirements and regulations; global regulatory understanding is preferred;
Ability to read, analyze and interpret complex data and review technical documents;
Excellent written and oral communication skills;
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency;
Legislation and regulation:
US CFR Title 21 (applicable sections)
IVDD & pending IVDR
GDPR
Various Market regulations, as assigned**
Planning & organization
Time & priority management: plans activities effectively with respect for priorities and deadlines.

Adaptability to change

Embracing change: is open for change and willing to adapt to changing tasks, priorities and unexpected events.

Resilience

Displays a positive attitude in the face of ambiguity, stress and change.

Communicating & influencing

Communicates with persuasion: presents, explains and defends a complex message in a clear and concise way and persuades different stakeholders

Analytical thinking

Conducts ongoing indepth analysis to anticipate potential problems and guides others in complex issues.
PC skills:
Applied knowledge of MS office (Outlook, Excel, Word, Powerpoint)
Applied knowledge of an ERP system, preferably Microsoft Dynamics AX
Languages: fluent English, written and spoken

Our offering
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package which includes a Flex