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Are you looking to start your career in Medical Device Regulatory Affairs? Maven Profcon Services LLP has announced an opportunity for candidates interested in building their professional career in the field of EU MDR and EU IVDR regulatory compliance.
The company is hiring for the position of Junior Regulatory Executive – EU MDR/IVDR at its Makarba, Ahmedabad location. This opportunity can be particularly relevant for candidates who have completed an internship involving European medical device regulations and want to transition into a full-time regulatory affairs role.
Candidates with educational backgrounds in Life Sciences, Biomedical Engineering, Pharmacy, or related disciplines may be eligible, provided they meet the required internship experience and technical knowledge criteria.
Maven Profcon Services Junior Regulatory Executive Job – Highlights
| Job Detail | Information |
|---|---|
| Company | Maven Profcon Services LLP |
| Position | Junior Regulatory Executive – EU MDR/IVDR |
| Job Location | Makarba, Ahmedabad, Gujarat |
| Employment Type | Full-time |
| Experience | Minimum 6 months internship experience |
| Relevant Experience | EU MDR/IVDR Medical Device Regulatory Affairs |
| Qualification | Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy or related field |
| Industry | Medical Devices / IVD / Regulatory Affairs |
| Application | Official Maven Profcon Services career page |
About Maven Profcon Services LLP
Maven Profcon Services LLP works in the areas of quality and regulatory affairs, supporting organizations operating in medical devices, in-vitro diagnostics and pharmaceutical-related industries.
Regulatory consulting plays an important role in helping medical technology companies understand applicable regulations, prepare technical documentation and work toward regulatory compliance for different markets.
For professionals interested in regulatory affairs, working in a consulting environment can provide exposure to different types of products, regulatory requirements and documentation activities.
Job Role: Junior Regulatory Executive – EU MDR/IVDR
As a Junior Regulatory Executive, the selected candidate is expected to support regulatory activities related to medical devices and IVD products.
The position involves working with regulatory documentation and assisting senior professionals with compliance-related activities. Candidates can gain practical exposure to important regulatory frameworks such as EU MDR 2017/745 and EU IVDR 2017/746.
The role may also provide exposure to regulatory activities associated with the US FDA 510(k) pathway.
This makes the position relevant for candidates who want to develop a long-term career in medical device regulatory affairs, quality assurance and global regulatory compliance.
Key Responsibilities
The Junior Regulatory Executive will assist with several regulatory and documentation activities.
1. Technical Documentation
Candidates will support the preparation, organization, maintenance and updating of technical documentation for medical devices and IVD products.
This can include working with technical files and design-related documentation while ensuring that required information is properly organized.
2. Risk Management Documentation
The role includes supporting regulatory documentation associated with risk management.
Candidates may work with Risk Management Files and gain familiarity with ISO 14971, which is an important standard in medical device risk management.
3. Clinical and Performance Evaluation Support
The selected candidate may assist with documentation related to Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
This provides useful exposure to the evidence and documentation requirements associated with medical device and IVD regulatory submissions.
4. Notified Body Submissions
Candidates will assist in preparing and compiling regulatory documentation for submission to Notified Bodies.
They may also help track regulatory questions and support the preparation of responses to technical queries under the guidance of senior regulatory professionals.
5. Regulatory Gap Assessment
The position involves supporting regulatory gap assessments.
Candidates may review existing technical documentation and help identify areas that require additional information or updates to meet applicable regulatory requirements.
6. FDA 510(k) Support
The role may also involve supporting the preparation of US FDA 510(k) documentation.
Candidates can gain exposure to areas such as predicate device identification and substantial equivalence assessments.
7. Cross-Functional Coordination
Regulatory professionals frequently work with teams such as engineering, manufacturing and quality assurance.
The selected candidate may assist in collecting testing information, verification documents, validation reports and other technical data required for regulatory documentation.
8. Regulatory Intelligence
Regulations and regulatory guidance continue to evolve. The candidate will therefore assist with tracking relevant regulatory updates and maintaining internal regulatory intelligence information.
Eligibility Criteria
Candidates interested in this opportunity should carefully review the required qualifications before applying.
Educational Qualification
Applicants should have a Bachelor’s degree in a relevant discipline such as:
- Life Sciences
- Biomedical Engineering
- Pharmacy
- Related scientific or technical fields
Experience Required
One of the important requirements for this position is at least six months of internship experience in Medical Device or IVD Regulatory Affairs, particularly involving EU MDR or EU IVDR.
Therefore, candidates should clearly mention relevant internship experience in their resumes.
Although this is a junior-level position, applicants should not assume that it is open to candidates with no relevant regulatory exposure. The stated internship requirement should be considered before applying.
Skills Required for the Role
Candidates should ideally have a basic understanding of:
- EU MDR 2017/745
- EU IVDR 2017/746
- Medical device classification
- CE marking processes
- Technical documentation
- ISO 13485
- ISO 14971
- Regulatory submissions
- Medical device regulatory requirements
Apart from technical knowledge, attention to detail is particularly important because regulatory affairs involves extensive documentation and compliance review.
Good written and verbal communication skills in English, organizational ability, time management and willingness to learn can also help candidates succeed in this type of role.
Why Consider a Career in Medical Device Regulatory Affairs?
Medical device regulatory affairs is a specialized career area connecting healthcare, science, documentation, quality systems and compliance.
Professionals working in this field can develop knowledge of regulatory frameworks used across different markets. EU MDR and EU IVDR have also increased the importance of structured regulatory documentation and compliance activities for organizations involved in medical devices and IVDs.
For graduates who are interested in healthcare but prefer a regulatory, documentation or compliance-oriented career rather than laboratory-based work, this can be an interesting career path.
A junior position can provide an opportunity to strengthen practical knowledge while working under experienced regulatory professionals.
How to Apply for Maven Profcon Services Jobs
Interested and eligible candidates should prepare an updated CV highlighting their educational qualifications and relevant EU MDR/IVDR internship experience.
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According to the vacancy information, candidates can apply through the company’s career page:
Application Website: https://mavenprofserv.com/career/
Candidates can also contact the organization for inquiries using the contact number provided in the vacancy information:
Contact: +91 7383367774
Before applying, candidates should review the latest information on the official career page and ensure that they meet the stated eligibility requirements.
Important Tips for Applicants
If you are applying for this Junior Regulatory Executive position, make sure your resume clearly highlights:
- EU MDR/IVDR internship experience
- Medical device or IVD regulatory exposure
- Knowledge of ISO 13485 and ISO 14971
- Technical documentation experience
- Regulatory research or gap assessment experience
- Academic projects related to medical devices
- Relevant certifications or training
Avoid submitting a generic resume. A targeted CV that clearly demonstrates your regulatory knowledge can make it easier for recruiters to understand your suitability for the role.
Frequently Asked Questions
Is this Maven Profcon Services job suitable for freshers?
It is a junior-level opportunity, but the stated requirement includes a minimum of six months of relevant internship experience in EU MDR/IVDR Regulatory Affairs. Candidates should therefore check the eligibility criteria carefully before applying.
What qualification is required?
A Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy or a related field is among the stated educational requirements.
Where is the job located?
The position is based in Makarba, Ahmedabad, Gujarat.
What regulatory knowledge is useful for this position?
Candidates should have familiarity with EU MDR, EU IVDR, ISO 13485, ISO 14971, CE marking and medical device regulatory documentation.
How can I apply?
Eligible candidates can visit the Maven Profcon Services career page and submit their updated resume through the available application process.
Final Words
The Maven Profcon Services Junior Regulatory Executive – EU MDR/IVDR opportunity can be worth considering for candidates who have completed relevant regulatory internships and want to establish themselves in the medical device regulatory affairs industry.
With exposure to technical documentation, risk management, clinical and performance evaluation, Notified Body submissions and regulatory compliance, the role can help junior professionals build practical knowledge of the regulatory environment.
If you meet the educational and internship requirements, review the latest vacancy information and apply through the official career page.
Disclaimer: Job seekers should independently verify the latest vacancy status, eligibility criteria, job location and application details on the employer’s official website before applying. JobsOnTheWay.com does not guarantee recruitment or selection.
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