Regulatory Affairs Manager - Mechelen, België - Biocartis

Biocartis

Geverifieerd bedrijf

Mechelen, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Publication date

29 November 2023

Location

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

Country

Belgium
United States
United Kingdom

Workplace type

Remote

Travel percentage

15%-25%

Department

Quality, Regulatory and Clinical Affairs

Function type

Full-time

Contract type

Employee

Experience required

Minimum 7 years of experience in Regulatory Affairs or supporting functions (clinical or quality assurance); 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;
Application of 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;
RAC Certification a plus.

Education

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

Regulatory Affairs Manager:

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

The Regulatory Affairs Manager will provide regulatory review of the product labeling, promotional material and e-labeling.

He or she will provide regulatory guidance to development teams, and manage post-market activities, including annual product reviews and medical device vigilance.

As a senior regulatory expert staff member, the Regulatory Affairs Manager takes the lead in providing RA expertise to assigned business areas and actively participates in Biocartis business development, product development and post market activities.

Accountabilities & responsibilities

Create regulatory strategy to efficiently obtain regulatory approvals for Biocartis' products including those for Companion/Complementary Diagnostic use;
Monitor and communicate regulatory requirements in various markets to ensure preparedness for upcoming changes;
Represent the company on working groups for IVDR or with US FDA;
Manage communications with local and international authorized representatives and regulatory authorities;
Conduct regulatory intelligence/research to assist in formulation of regulatory plans;
Manage projects designated for regulatory affairs;
Work closely with R&D teams to implement development efforts compliant to the IVDD, pending IVDR, US 21 CFR 820, and global regulatory requirements;
Review and edit technical documentation including:
Product Validation Protocols and Reports
Software documentation
Risk Management documentation;
Ensure design control is maintained through review and scrutiny of proposed product changes; establish change management plans when needed;
Review of product marketing materials to ensure conformity with product claims;
Review product complaints for compliance to vigilance procedures;
Participate in periodic post market product data analysis processes; manage postmarket reporting requirements;
Represent Regulatory Affairs in audits/internal audits and inspections as appropriate;
Liaise closely with sales in support of registering products in the desired territories;
Liaise closely with thirdparty development organisations on regulatory development projects, ensuring projects are delivered to time, cost and quality objectives;
Liaise with distributors and third party local representatives to register products in the local territories;
Write and manage regulatory SOPs.

As a senior regulatory expert staff member, the Regulatory Affairs Manager takes the lead in providing regulatory intelligence and (pro)actively bringing regulatory expertise to Product Development, Business Development, post market and Corporate Leadership to achieve defined business objectives.

Profile requirements

Bachelor's or Master's degree with preference for scientific, engineering or legal studies or equivalent through experience/training;
Minimum 7 years of experience in Regulatory Affairs or supporting functions (clinical or quality assurance); 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