Introduction

What are you going to do 

Our client is a fast-growing and stable Medical Devices MNC, with a strong product pipeline

Regulatory Strategy: Develop and implement regulatory strategies to support the registration and approval of medical devices in domestic and international markets.

Regulatory Submissions: Prepare, review, and submit regulatory dossiers, including 510(k)s, premarket approval applications (PMA), CE Mark applications, and other submissions, ensuring accuracy and completeness.

Product Classification: Determine the appropriate regulatory pathway and classification for new and existing medical devices.

Labeling and Packaging: Review and approve product labeling, packaging, and marketing materials to ensure compliance with regulatory requirements.

Post-Market Surveillance:Support post-market surveillance activities, including adverse event reporting, field actions, and product recalls, as necessary.

Regulatory Intelligence: Stay informed about changes in medical device regulations, guidelines, and standards, and communicate relevant updates to the organization.

Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to provide regulatory guidance and support throughout the product lifecycle.

Regulatory Audits:Prepare for and participate in regulatory agency audits, inspections, and notified body assessments.

Training and Guidance: Provide training and mentorship to junior members of the regulatory affairs team and other relevant departments.

(Registration Number: 199603098R | Company License Number : 16S8067 Consultant License Number R2198025.)

Essential skills and knowledge 

What we offer

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Application process

First Contact

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.

Scheduling an Interview

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.

Phone/ Qualification Interview

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

Meeting in Real Life

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth  interview to review your communication and interpersonal skills.

Application for the Position

Submission of candidates resume for client’s approval and screening.

Are you the perfect match for this vacancy? Apply in 1 minute and let's get in touch!

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