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Regulatory Affairs Consultant
vor 2 Monaten
Who we are?
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.
If this excites you, then apply below.
Summary: Indegene is looking for a Germany -based Consultant with Regulatory or Compliance or Nominated Signatory Review experience for Medical Devices promotional and scientific communication materials on 3-4 months contract starting October 2024. The regulatory consultant will work with Indegene’s material review team to support its engagement with the medical device client partner and serve as a consultant to assist as an MLR SME (especially on medical device promotion regulations) on a medical device project.
Background: Indegene partners with life science organizations to provide effective, AI-enabled material review and compliance solutions. We provide comprehensive medical, regulatory, and editorial review services as well as operations support through a team of 350+ experienced professionals. We have a good knowledge of key market regulations and codes of practice and our span of operations covers North American, European, and Asia-Pacific regions.
Roles and responsibilities: As a Medical Device Consultant for Regulatory or Compliance or Nominated Signatory Review of Promotional and Scientific Communication Materials, you will be responsible for providing expert Germany Medical Device Promotion related Regulatory advice to the Indegene team with direct or indirect involvement in the client project, ensuring the client project requirements are met.
Provide guidance on standards pertaining to advertising and promotion of medical devices in Germany (and if possible, in EU and global regions).
Provide guidance on Germany Regulatory Requirements for promotional material review for medical devices
Provide guidance on review workflow for medical device promotional materials for Germany market
Provide strategic input and guidance on regulatory affairs matters, including understanding the collaboration between global and local markets for medical device promotional materials and associated review workflow for repurposing content, understanding regulatory submission guidelines, filing, negotiations, and amendments, which includes obtaining, assessing and summarizing scientific and other technical information specific for Germany market
Qualifications:
- Life science graduate/post-graduate
- Regulatory Affairs/Compliance professional with experience in Medical Device regulations and standards for device promotion and scientific communication, with 2 years’ experience in review and approval of medical device promotional and non-promotional materials.
- Strong foundation in medical device regulatory affairs, with a total of 2-3 years working with a range of medical devices (Class 2 and above is preferred)
- Has experience with and understands Germany, EU and global medical device regulations
- Ability to build and maintain strong and collaborative working relationships with internal and external contacts
- Ability to analyse complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders
NOTE: Please upload CV in English.
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
