26/04 Pooja
Technical Recruiter at Inito

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Manager - Regulatory Affairs (5-10 yrs)

Bangalore Job Code: 18039

The responsibilities we'll trust you with : 

- Developing the regulatory strategy for multiple products across US, EU, India, South East Asia and other geographies.

- Managing the activities of Regulatory Affairs, ensuring the implementation of appropriate and effective regulatory strategies.


- Oversees quality efforts in the organization and planning training for the team to ensure everyone is updated with current regulations.

- Building a strong team, managing and being responsible for QAs and technical writers.

- Developing, implementing, and reviewing SOPs, providing regulatory input to product lifecycle planning.

- Planning and implementing trials and regulatory inspections, keeping up-to-date with changes in regulatory legislation and guidelines.

- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

- Developing functional annual operating budgets for Regulatory Affairs to meet long-term company and department objectives.

- Conducting regular internal audits to emphasize on preventive measurements and face external audits from regulatory agencies.

Looking for someone with :

- 5-8 years of experience working in the medical device or related industry with direct extensive experience leading a team in Regulatory Affairs.

- Knowledge of Medical/Technical writing, Advertising and promotion, Labelling,

Controlled substances, standards, Import / export, quality assurance, and Country specific regulatory support.

- Extensive knowledge and experience of U.S. and/or European/International regulations and standards, such as

- ISO 13485, ISO 14971

- 21 CFR Part 820

- IEC 61010,IEC 62304, IEC 62366,

- ISO 15197, ISO 15223,

- EU MDR and EU IVDR

- Along with CE Certification and Surveillance audits

- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

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