Manager - Regulatory Affairs

Duties and Responsibilities:

 Responsible for strategic development, implementation, maintenance, and overall success of

the company’s regulatory project approvals in different countries.

 Develop, implement, and support a comprehensive regulatory compliance strategy to meet

global market requirements for our products and ensure alignment with our overall business

strategy.

 Regulatory affairs strategy and coordination with Internal and external team for Asia, Africa,

ANZ, Middle East, Europe and LATAM countries.

 Coordinate with the Sales & Marketing team for business continuity and center of contact for

all regulatory matters.

 Global coordination for regulatory planning and execution, for the development and market

introduction of Biotek Products

 Regulatory compliance and medical device registration in Asia, Africa, ANZ, Middle East,

Europe and LATAM countries. Management of a team of RA coordinators for different

countries.

 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 9 years of extensive

experience in medical device regulatory affairs, preferably in Implants.

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.

Job Types: Full-time, Permanent

Pay: ₹2,000,000.00 - ₹2,200,000.00 per year

Benefits:

• Food provided
• Health insurance
• Paid sick time
• Provident Fund

Schedule:

• Day shift
• Rotational shift
• Weekend availability

Supplemental Pay:

• Joining bonus
• Performance bonus
• Quarterly bonus
• Shift allowance
• Yearly bonus

Work Location: In person