Chetan Meditech Pvt. Ltd. - India
Website:
biotekortho.net
Job details:
About Us:
BIOTEK is a global medical device company focusing on new product development in the most advanced Orthopaedic sector: SPORTS MEDICINE. With presence on all six continents worldwide, the growth and demand for our products around the globe is unprecedented.
We are looking for Urgent requirement of Deputy Manager-Regulatory Affairs to join our team!
As a Deputy Manager- Regulatory Affairs, you will play a pivotal role in shaping our company's regulatory approach, from product inception through to market launch. You will collaborate closely with cross-functional teams to ensure that all regulatory requirements are met, while also keeping abreast of evolving regulations and industry trends. Your ability to provide clear, actionable insights and maintain strong relationships with regulatory bodies will be key to driving our success in a highly regulated industry.
Location: Ahmedabad
Experience: Atleast 8 Years of experience in medical device regulatory domain, with exposure to FDA 510(k) submission
Duties and Responsibilities:
Responsible for strategic development, implementation, maintenance, and overall success of the company’s regulatory project approvals in different countries.
Develop and implement regulatory strategies to ensure timely market access and compliance with US FDA, EU MDR, ISO 13485, and other global regulatory bodies.
Regulatory affairs strategy and coordination with Internal and external team for Asia, Africa, ANZ, Middle East, Europe and LATAM countries.
Oversee the preparation and submission of regulatory dossiers, including FDA 510(k), PMA, CE marking, and international registrations.
Lead and maintain the company’s QMS, ensuring compliance with ISO 13485, MDSAP, ISO 14971, FDA QMSR and other applicable standards.
Coordinate with the Sales & Marketing team for business continuity and center of contact for all regulatory matters.
Manage regulatory interactions with government agencies – FDA for Q-sub, Pre-sub meetings, and notified bodies, serving as the primary contact for inspections, audits, and inquiries.
Ensure effective post-market surveillance, including adverse event reporting, recalls, and compliance monitoring.
Lead a cross-functional team, providing mentorship and ensuring alignment with regulatory and quality goals.
Global coordination for regulatory planning and execution, for the development and market introduction of Biotek Products
Having knowledge surrounding Regulatory compliance and medical device registration processes in Asia, Africa, ANZ, Middle East, Europe and LATAM countries.
Having experience with Regulatory work management.
Stay abreast of global regulatory changes and proactively advise senior leadership on potential impacts to the company’s products and strategy.
Drive continuous improvement initiatives in regulatory processes and quality systems.
Manage post approval changes in Global market for all Biotek products
Ensure that regulated processes and systems are always inspection ready.
Draft, review, edit, and maintain all departmental policies and procedures, including Post approval changes, regulatory review of order, label and IFU requirements, Language translation needs, Marketing claims etc.
Manage, train and guide the team members as and when required.
Willingness to undertake other reasonable tasks within the scope of the position as instructed by the supervisor.
Education and Professional Experience:
Bachelors or Masters in Pharma/Engineering/life sciences with minimum 8-10 years of extensive experience in medical device regulatory affairs, preferably in Implantable submissions to US FDA and EU MDR.
Skills & Abilities:
Strong experience hosting regulatory inspections and interacting with regulators, Consultants, Customer, sales persons
Strong understanding of global registration requirements and demonstrated track record of successful market access.
Highly experienced in setting up the Regulatory requirement compliances as per ISO 13485 and MDSAP and maintaining the same.
Experience on areas such as EU MDR, ISO 14971, 510(k) submissions, Indian MDR, and post market surveillance would be preferred.
Proven ability to create culture of accountability and ownership
Proven track record with establishing and maintaining strong internal and external partnerships.
Must be able to work effectively at all levels in the organization in a matrix environment and with external partners.
Must demonstrate excellent written and verbal communication skills in English and work well with diverse teams and stakeholders in multiple locations.
Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.
Highly independent and self-motivated and integrates well within a team.
Proven project management skills
Excellent presentation skills.
Structured and results-oriented approach.
Strong time management skills.
Proficiency in MS Office programs.
Interested candidate can drop CV at hr1@biotekortho.com with their total experience in medical device regulatory affairs, Products worked with, Current CTC, Expected CTC and Notice period.
Mail Subject Line: CV for Regulatory Affairs Deputy Manager at Biotek Ortho (Your Experience in years)
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